research investigator job description

• Principal Investigator

Principal Investigator (PI)

• OVERALL ROLE/RESPONSIBILITY
• ADMINISTRATION
• PROPOSALS & AWARDS
•  Pre-Award
•  Post-Award

Material Transfer Agreements (MTA)

•  Closeout
•  Effort Reporting
• RESEARCH CONDUCT
•  Human Research Participants

Clinical Trials

Animal subjects.

•  Research Safety
•  Research Integrity
•  Conflict of Interest
•  Patents and Inventions
•  Export Controls

Research Admin Units

• Center for Comparative Medicine (CCM)
• Institutional Animal Care and Use Committee Office (IACUC)
• Innovation and New Ventures Office (INVO)
• Institutional Review Board Office (IRB)

Export Controls & International Compliance

• Research Administrative Offices
• Research Communications
• Research Development (ORD)
• Research Financial Administration

Research Integrity

• Research IT

Research Safety

• Sponsored Research
• University Research Institutes and Center Administration (URICA)

Overall Role/Responsibility

Direct and oversee all research activities and foster a culture of research integrity. Responsible for fiscal and administrative management of research. Conduct research in an objective and unbiased manner in compliance with policies and regulations. While the PI may delegate responsibility for some project activity to others, the PI is ultimately responsible for compliance with all applicable regulations and policies and for ensuring a safe research environment, meaning one that is inclusive and free from any form of discrimination or harassment.

Northwestern University researchers can use this chart to pre-determine Principal Investigator eligibility to serve on an  IRB  protocol,  IACUC  protocol or a  Sponsored Research  proposal/award.

Administration

• Manage research staff, including co-investigators, post-doctoral trainees, fellows, students, technicians and lab managers
• Oversee the training and mentoring of post-doctoral trainees, fellows, and students
• Assure that all key research personnel have met training requirements
• Coordinate with school, department, and central administration to ensure that sponsored research activities are in accordance with all applicable regulations, policies, and procedures
• Ensure appropriate resources for research conduct
• Review, prepare, and submit results for publication and register publication, as required by sponsor

Proposals and Awards

Proposal submission.

• Review funding opportunity announcements
• Prepare technical and/or scientific proposal
• Develop and coordinate budgets, administrative elements, and materials, including materials for subcontracts
• Coordinate large proposals with the Office of Research Development (ORD)
• Understand and comply with institutional limited submission process
• Complete proposal application and submissions by required deadlines

Pre-Award Set-Up

• Ensure pre-spending (at-risk/advance) accounts are requested from Sponsored Research
• Complete “Just In Time” documentation requests from sponsor
• Provide estimate of sponsored project effort percentage
• Modify project scope and coordinate all administrative items, including budget, as necessary
• Direct all technical and administrative activities
• Review and confirm notice of award and award setup, including budget reconciliation
• Request issuance of subcontracts
• Review and approve any revisions to project scope, budget or changes in effort or other activities that may require prior approval from sponsor
• Monitor expenditures regularly to ensure that funds are managed in compliance with sponsor terms and conditions and only expended to directly support and benefit the project
• Ensure the accurate and timely submission of all required reports throughout the life of the award
• Confirm that all award records and data are maintained accurately and consistently over the award life cycle and through the sponsor and University’s records retention period
• Monitor subrecipient and consultant activity, including review and approval of invoices
• Responsible for deficits and disallowances incurred against an award
• Oversee confirmation and monitoring of program income
• Coordinate with the Accounting Services for Research and Sponsored Programs (ASRSP) office for all financial matters including fiscal compliance, cash application, financial audits, and effort reporting
• Communicate plans to transfer a grant to the sponsor, Sponsored Research, and other institutions
• Initiate a request to Sponsored Research for an MTA prior to any materials being sent to collaborators
• Review and approve all project expenses to ensure completion and compliance, including financial reports, final invoices, program income, and subrecipient performance
• Oversee completion of closeout documentation and ensure that all reporting requirements are met
• Confirm that all periodic and final technical and invention reports are submitted
• Work with ASRSP to resolve sponsored funds collection issues
• Certify budget statements at the end of the award

Effort Reporting

• Complete effort commitment profile
• Complete salary planning and distribution
• Disclose existence of appointments at other institutions to departmental chair
• Disclose and notify chair and dean when proposing cost share for proposal submission
• Fulfill and manage effort commitments of project members
• Certify effort by the required deadline
• Resolve effort discrepancies
• Ensure appropriate training of project staff

Research Conduct

Human research participants.

• Ensure the protection of the rights and welfare of human research participants
• Oversee submission to, and approval by, the Institutional Review Board (IRB) and confirm protocol/grant congruency
• Ensure the IRB approves the protocol prior to initiation
• Conduct all human participant research according to the approved protocol, relevant regulations, laws, institutional policies, and the Investigator Manual (HRP-103)
• Obtain IRB approval prior to the initiation of modifications to a study, except for those changes that are implemented to eliminate immediate hazards to participants
• Respond to all compliance issues, including participating in post-approval monitoring
• Confirm and monitor that the research team is trained and in compliance with IRB policies and procedures, federal and state regulations, and other relevant University policies
• Promptly suspend or terminate research, as appropriate, and submit reports of these actions and other reportable events to the IRB via Reportable New Information (RNIs) submissions
• Ensure clinical trials are conducted in accordance with Good Clinical Practice (GCP)
• Work with staff to prepare and submit case report forms for clinical trials
• Follow required closeout procedures (see ASRSP)
• Maintain current and accurate records in the Clinicaltrials.gov database
• Oversee animal study protocol submission to, and approval by, the Institutional Animal Care and Use Committee (IACUC) and provide a full copy of grant for protocol/grant congruency
• Ensure that the animal study protocol is IACUC approved prior to implementing animal work and that all aspects of animal care and use are conducted according to the approved protocol
• Ensure each grant has a separate approved animal study protocol
• Review/confirm animal charges and reconcile with the Center for Comparative Medicine (CCM)
• Confirm and monitor that research team is trained and qualified for the procedures they will perform, including compliance with all Occupational Health and Safety enrollment requirements
• Comply with all federal, state and local regulatory and institutional inspections and compliance investigations
• Inform the IACUC Office when custom antibodies or tissues are obtained from a third party
• Notify the IACUC Office of external collaborations involving animal work
• Notify the IACUC Office of animal work supported by funds from another institution
• Participate in Post-Approval Monitoring (PAM) visits
• Model, demonstrate and enforce safety and health compliance
• Mentor trainees and lab staff in relation to safety issues
• Register lab with Research Safety and keep research profile current
• Ensure consistent use of proper protective clothing and usage of materials
• Report any incidents that occurred during the performance of laboratory work activities that resulted in or could have led to injury or damage to property.
• Ensure that all lab members leaving the lab have cleaned up their assigned spaces before they depart
• Conduct research in an ethical and compliant manner
• Ensure integrity of all research activities and data
• Uphold secure and ethical data use, data confidentiality, and compliant data management, sharing, ownership, and retention practices
• Supervise and ensure the integrity of the research of all trainees and research staff
• Ensure Responsible and Ethical Conduct of Research (RECR) training for NSF supported undergraduate students, graduate students, and post-doctoral fellows as well as all trainees, participants, and scholars supported through applicable NIH awards
• Implement and follow responsible authorship practices, including adherence to discipline-specific guidelines

Conflict of Interest (COI)

• Meet initial and ongoing Conflict of Interest (COI) training and disclosure requirements
• Identify which individuals on the study team meet the definition of "investigator" and are subject to the COI requirements
• Adhere to the requirements of COI management plans
• Adhere to COI policies and processes and to all federal, state, and local regulations and sponsoring agency policies and procedures

Patents and Inventions

• Promptly disclose all inventions to the Innovation and New Ventures Office (INVO) using the on-line Inventor Portal must be completed at least 3-4 weeks prior to public disclosure)
• Provide accurate sources of funding on the Invention Disclosure form
• Communicate timely information to INVO, such as chartstring and/or account information, confidentiality agreements, technology development updates, etc.
• Adhere to Northwestern’s Export Control Compliance Policy and federal policies
• Adhere to federal regulations related to malign foreign talent programs
• Review and follow improper foreign interference guidelines
• Report potential research security issues to the Export Controls & International Compliance team

Clinical Researcher

The Clinical Research Investigator: Clarifying the Misconceptions

Clinical Researcher February 15, 2022

Clinical Researcher—February 2022 (Volume 36, Issue 1)

PEER REVIEWED

Steven Eric Ceh, DPM

The terms “investigator,” “co-investigator,” “clinical investigator,” “principal investigator,” “co-principal investigator,” “study principal investigator,” and “sub-investigator” are often used loosely. This article clarifies the roles and responsibilities for each term according to U.S. regulations and international guidance, with the following factors in mind:

• The terms investigator, principal investigator, and clinical investigator are interrelated but not necessarily synonymous.
• Sub-investigators are individual members of the research team and are not equivalent to investigators.
• Co-investigator and co-principal investigator are uncommon, misunderstood terms.
• Clinical investigator, as described in 21 CFR Part 54 in the Code of Federal Regulations, {1} differs from the term used in 21 CFR Parts 312 and 812, which is a cause for confusion.

Detailed information and discussion follow, with a review of key references that will provide clarity for these terms.

How Are These Terms Defined?

21 CFR 312.3 states that “investigator” means “an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject).” Similarly, 21 CFR 812.3 states that “investigator” means “an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered to, or used involving, a subject …” Both of these definitions also specify: “In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.” 21 CFR 312.53(a) states that investigators are “qualified by training and experience as appropriate experts to investigate the drug.”

The International Council for Harmonization E6(R2) Good Clinical Practice (ICH GCP) guideline{2} states in section 1.34 that an investigator is “a person responsible for the conduct of a clinical trial at a trial site.” It further states: “If a trial is conducted by a team of individuals at a site, the investigator…may be called the principal investigator.” Therefore, the term principal investigator is an appropriate term whenever there are one or more team individuals in addition to a single investigator. However, “investigator” is primarily used throughout the regulations. The term co-principal investigator is not defined, as it is not possible to have more than one outright leader and, therefore, should not be used. Also, study sponsors will sometimes designate an investigator in a multisite study to be the study principal investigator and team leader over the other site investigators.

ICH GCP 4.4.1 adds that an investigator “should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial and should meet all the qualifications specified by the applicable regulatory requirement(s) and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the [institutional review board/institutional ethics committee (IRB/IEC)] and/or the regulatory authority(ies).” ICH GCP 2.7 adds that “the medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.”

The U.S. Food and Drug Administration (FDA) Compliance Program Manual 7348.811 for the agency’s Bioresearch Monitoring (BIMO) Program utilizes the term “clinical investigator” and states{3}:

A clinical investigator is the individual who conducts the clinical investigation. The clinical investigator is responsible for overall conduct of the study at the clinical site, including directing the administration or dispensing of the investigational product to the subject and ensuring that data are collected and maintained in accordance with the protocol and applicable regulatory requirements. When the investigation is conducted by a team of individuals, the clinical investigator is the responsible leader of the team.

With that, the term clinical investigator encompasses “investigator” as stated in 21 CFR 312 and 812 and “principal investigator” as stated in ICH GCP 1.34.

The term “clinical investigator” is also used in a document on “Financial Disclosure by Clinical Investigators—Guidance for Clinical Investigators, Industry, and FDA Staff” from 2013.{4} Those individuals who would be clinical investigators under 21 CFR Part 54 are individuals listed on lines 1 and 6 of the Form FDA 1572 (Statement of Investigator) (drug study) and the investigator and all individuals designated by him/her as sub-investigators (device study). Therefore, one must be careful of the context when referring to an individual as a clinical investigator. How the terminology differs from that of 21 CFR Parts 312 and 812 is further discussed below.

In a 2010 document on “Frequently Asked Questions—Statement of Investigator (Form FDA 1572)—Guidance for Sponsors, Clinical Investigators, and IRBs,”{5} question 21 addresses the term co-investigator and states:

As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all the obligations of an investigator as identified in 21 CFR 312.60. Thus, under 21 CFR 312.3(b), each co-investigator is an investigator, and as such must sign a separate 1572.

Who Can be a Principal Investigator?

Section 505 of the Food, Drug, and Cosmetic (FD&C) Act{6} requires the FDA to ensure that the investigational drug will be provided only to investigators who are “experts qualified by training and experience to investigate a new drug.”

The FDA has the following to say about non-physicians as investigators:

While technically a non-physician can be an investigator, this requires that the non-physician be qualified to personally conduct or personally supervise all aspects of the study. In practice, we have found it rare that a non-physician can comply with this requirement. In general, where we have seen non-physicians on the Form FDA 1572 as an investigator, we usually would find an MD as a sub-investigator to perform those study functions requiring the appropriate level of medical expertise.

Qualified individuals who are not (MDs/licensed physician) can participate in clinical trials as an investigator or sub-investigator provided that an MD, DO, DPM, or D.D.S. is listed in the [Investigational New Drug application] as an individual who will be responsible for diagnosis and treatment of disease, drug administration, and evaluation of safety .{7}

An FDA Office of Medical Policy communication has stated the following{8}:

P rotocol-required tasks must be performed by the individuals specified in the protocol. For example, if the state [or jurisdiction] in which the study site is located permits a nurse practitioner or physician’s assistant to perform physical examinations under the supervision of a physician, but the protocol specifies that physical examinations must be done by a physician, then a physician must perform such exams.

As a result, a clinical psychologist could serve as investigator with an MD sub-investigator. Similarly, a Doctor of Pharmacy could serve as investigator of a pharmacological study with an MD sub-investigator. In theory, anyone qualified to conduct a clinical study who is not an MD or dentist could be an investigator, provided an MD or dentist handles the medical (or dental) decisions and care as sub-investigator or co-investigator.{7}

Nurse practitioners have full medical practice privileges in 22 states: Alaska, Arizona, Colorado, Connecticut, Hawaii, Idaho, Iowa, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, Rhode Island, South Dakota, Vermont, Washington, and Wyoming, as well as the District of Columbia.{9,10} In these states, nurse practitioners can be autonomous principal investigators; other similar emerging autonomous roles for nurses (e.g., advanced practice registered nurse [APRN]) are occurring in some states. However, that is currently not the case for physician assistants, who still work under the supervision of a physician, although there is currently legislation in several states to allow them to be independent practitioners.

Lastly, there can be instances where other healthcare practitioner/specialists can be an autonomous investigator based on their expertise, training, licensure, and the scope of the investigative study. Such an example would be an optometrist (OD) serving as the investigator on a study evaluating marketed pharmaceutical products or medical devices (e.g., contact lenses, lens care products, punctal plugs) where the inclusion of an MD on the 1572 or equivalent medical device form is not necessary.

Sponsors are responsible for selecting qualified investigators and often have the opportunity to discuss investigator qualifications with FDA prior to study implementation. The FDA’s acceptance of an investigator may vary with the FDA division, the indication, safety risk, study phase, and approval status, but this individual should always be an expert qualified by training and experience to investigate a new drug or device.

Who Must Make Financial Disclosures?

The aforementioned FDA guidance on “Financial Disclosure by Clinical Investigators” states the following{4}:

Section III A specifies the individuals for whom reporting under this regulation is required. Generally, these individuals are the investigators and sub-investigators taking responsibility for the study at a given study site. The sub-investigators are delineated in Section 6 of the Form FDA 1572 completed by the investigator. The definition also includes the spouse and dependent children of each investigator or sub-investigator.

For purposes of [21 CFR Part 54], “clinical investigator” means a “listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of research subjects,” including the spouse and each dependent child of the investigator or sub-investigator. (See 21 CFR § 54.2(d).).

Therefore, this would be the investigator and all of the individuals designated by him/her as sub-investigators (i.e., other physicians, pharmacists, research fellows, residents, study coordinators, data coordinators, etc.).

Section IV D of this guidance discusses how the above definition differs and is otherwise not equivalent with investigators as defined in 21 CFR 312 and 812:

For drugs and biological products, an investigator under 21 CFR Part 312 is defined as “an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.” This is the individual listed on line 1 of the Form FDA 1572 of a research site.

For medical devices, investigator is defined under 21 CFR Part 812 as “an individual under whose immediate direction the subject is treated and the investigational device is administered, including follow-up evaluations and treatments. Where an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. (21 CFR § 812.3(i).)” This is the individual listed as the investigator on the medical device study Investigator Agreement.

Who is a Sub-Investigator?

The aforementioned FDA resource on “Frequently Asked Questions—Statement of Investigator (Form FDA 1572),” under Question 31, discusses how investigators and sub-investigators are defined and documented in a clinical study{5}:

FDA regulation 21 CFR 312.3(b) states: “In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. ‘Sub-investigator’ includes any other individual member of that team.’ 21 CFR 312.53(c)(1)(viii) requires the investigator to provide ‘a list of the names of the sub-investigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s).’”

The purpose of Section #6 is to capture information about individuals who, as part of an investigative team, will assist the investigator and make a direct and significant contribution to the data. The decision to list an individual in Section #6 depends on his/her level of responsibility (i.e., whether they are performing significant clinical investigation-related duties). In general, if an individual is directly involved in the performance of procedures required by the protocol and the collection of data, that person should be listed on the 1572. For example, if the protocol notes that each subject needs to visit a specified internist who will perform a full physical to qualify subjects for the clinical investigation, that internist should be listed in Section #6.”

It is important to note that some sub-investigators will be licensed physicians/practitioners who were at one time an investigator for a study or have the qualifications to be one and thereby be appropriate for delegation of certain duties by the principal investigator. Further, sub-investigators have no automatic responsibilities—only those which are delegated to him/her by the investigator and which he/she is qualified to do.

Questions 32 and 33 offer clarification as to whether hospital staff, nurses, residents, fellows, office staff, pharmacists, or research coordinators should be listed on the 1572:

It is a matter of judgment, dependent upon the contribution that the individual makes to the study. For example, a research pharmacist may prepare test articles and maintain drug accountability for many clinical studies that are ongoing concurrently at an institution. Because the pharmacist would not be making a direct and significant contribution to the data for a particular study, it would not be necessary to list the pharmacist as a sub-investigator in Section #6, but he/she should be listed in the investigator’s study records.

Generally, a research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572 .

However, according to an informal response from FDA,{11} the Center for Devices and Radiologic Health would not consider research study coordinators to be sub-investigators unless they had the required expertise/training to also perform study-related procedures and this was noted on the study delegation log.

Sub-Investigators and the Assessment of Adverse Events

Just because someone is listed in the aforementioned Section #6 of Form FDA 1572 as a sub-investigator who will be assisting the investigator in the conduct of the investigation(s) does not mean they are qualified to be an investigator, can perform an investigator’s tasks, or bear an investigator’s responsibilities.

Per formal communication{8} with the Office of Medical Policy:

Listing someone [in Section #6] does not equate them to an investigator. In addition, the investigator is responsible for ensuring that any individual to whom a task is delegated is ‘qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task’—and is not assumed to be qualified only on the basis of belonging to a particular category of healthcare professional nor only from having been included [in Section #6] of Form FDA 1572. Per 21 CFR 312.3, sub-investigator means any other individual member of that (clinical) team.

The FDA also indicates “a sub-investigator role in the clinical investigation is more limited.”{5} A specific case in point is registered nurses performing causality assessments under the guise of being considered clinical investigators when included in Section #6 of Form FDA 1572 or clinical investigators per the financial disclosure regulation.

The following formal communications and references{12} offer clarity:

• “While the investigator can delegate tasks to others in a study, it appears the investigator should assess Adverse Event (AE) causality and severity and report his/her findings to the sponsor. The investigator is required to report serious [AEs] to the sponsor and must include an assessment on whether there is a reasonable possibility that the drug caused the event (21 CFR 312.64). The sponsor is required to report serious and unexpected suspected adverse reactions to FDA and all participating investigators (21 CFR 312.32(c)(1). That said, much of this depends upon who is required by the study protocol to make the AE causality and severity decision. If the sponsor specifically wants it to be made by the clinical investigator, then the investigator would be incorrect in delegating this responsibility and it would be considered a protocol deviation to do so.”
• “Assessment of causality when evaluating [AEs] by the investigator is a complex clinical determination that requires an understanding of the risks of the investigational agent and an assessment of the totality of clinical factors related to the event, and such assessments are done typically by a licensed physician, whose qualifications are captured in Section 2 (of the Form FDA 1572).”
• The FDA Compliance Program 7348.811 Manual further implies that a clinical investigator should be performing safety AE evaluations and determined as such by the FDA Field Inspector when conducting a site inspection so, having someone other than a clinical investigator perform the assessment would pose an audit risk. The Field Inspector is to: “Compare the source documents with [case report forms] and any background information provided (e.g., data tabulations provided by the sponsor) per the assignment memorandum and sampling plan (if applicable) and… Determine: The clinical investigator assessed the severity of the [AE] and documented the relationship of the event to the test article, including any [AE] that was previously anticipated and documented by written information from the sponsor. Determine: The clinical investigator assessed safety monitoring, including documentation of [AEs] (or other treatment-related safety concerns), assessment of the severity of the [AE] and relationship of the [AE] to the investigational product, and any changes to the subject’s participation on the study related to the [AEs] (e.g., study discontinuation/termination).”

The rules above for assessing AE causation also apply to signing lab reports and any other responsibility that requires the expertise of a physician or dentist.

Responsibilities Listed On the Form FDA 1572

Form FDA 1572 does not list all investigator responsibilities. Per the 2009 guidance for industry on “Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects,”{13} a more comprehensive listing of FDA’s requirements for the conduct of device, drug and biologics studies by investigators is found in 21 CFR Parts 11, 50, 54, 56, and 312/812.

Obtaining Informed Consent

In many states, the investigator has a specific role in or related to the informed consent process that cannot necessarily be delegated. The following are some examples:

Pennsylvania. A Pennsylvania Supreme Court ruling in the case of Shinal v. Toms, M.D. stated that a physician must obtain informed consent.{14}

Indiana. A patient who has given informed consent for administration of experimental treatment in a clinical trial can only receive the treatment if a licensed physician has personally examined the subject and agreed to treat them. Mental health patients must be informed of the investigator’s credentials.{15}

Minnesota. Subjects in state hospitals require the investigator to provide certification that the subject is competent to consent.{16}

Montana. If a subject is a resident of a mental health facility, the investigator must send a notice of intent to enroll to the subject, their next of kin, and their attorney.{17}

California. An investigator who negligently allows or willfully fails to obtain a subject’s consent is liable for fines to be paid to the subject per California Health and Safety Code §24176.{18} The state also requires all subjects be given a copy of California’s Experimental Subject Bill of Rights (California Health and Safety Code §24172).{19}

Other states in which the investigator has specifications or requirements for certain types of subjects include Delaware, Illinois, Maine, Missouri, Nevada, New Hampshire, New York, North Carolina, Oregon, Texas, Utah, and Wisconsin. Please note, each state’s rules vary and a complete analysis is beyond the scope of the current article.

After evaluating all of the definitions and clarifications of misconceptions, we could expect that the investigator for a clinical trial will be a licensed physician identified as an investigator (or clinical investigator) in initial submissions or protocol amendments under an Investigational New Drug/Investigational Device Exemption whose name is listed in Section 1, qualifications (by training and experience as an appropriate expert to investigate the drug) are captured in Section 2, and who completes and signs the Form FDA 1572 (Statement of Investigator), assumes the responsibilities denoted on it including those outlined in 21 CFR Parts 11, 50, 54, 56, and 312/812, and completes a financial disclosure form. When the investigation is conducted by a team of individuals, the clinical investigator is the responsible leader of the team and is called the principal investigator.

In a small number of cases, an investigator can be an autonomous practitioner/specialist such as a nurse practitioner who meets the education, training, and experience requirements noted in 22 states and the District of Columbia.

Although very uncommon, there are scenarios where an investigator need not be a licensed physician, provided that a licensed physician(s) be included on the Form FDA 1572 as a sub-investigator to handle patient assessments, make medical decisions, provide care, and perform some or all safety review including AE severity and causality assessments. Responsibilities listed on the Form FDA 1572 and 21 CFR Parts 11, 50, 54, 56, and 312/812 therefore need to be handled by multiple personnel, including at least one licensed physician.

Equally uncommon is the use of co-investigators at a clinical site , both of whom would separately sign a Form FDA 1572. This would include at least one licensed physician/practitioner whose shared responsibility and leadership with another investigator would not necessarily be equal , but would include all obligations required of an investigator.

• Title 21 of the Code of Federal Regulations at https://www.ecfr.gov/current/title-21 .
• ICH Good Clinical Practice E6(R2) at https://www.ich.org/page/efficacy-guidelines .
• The FDA BIMO Compliance Program Manual 7348.811 at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-manual/bioresearch-monitoring-program-bimo-compliance-programs .
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/financial-disclosure-clinical-investigators
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-statement-investigator-form-fda-1572
• See information on Section 505 of the FD&C Act at https://biotech.law.lsu.edu/blaw/fda/fdcact5a.htm . FD&C Act Chapter 5 on Drugs and Devices can be viewed at https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices .
• Barnett International. GCP: A Question & Answer Reference Guide, Section 2: Investigators/Sites. (Outdated edition)
• Per communication between the author and the FDA Office of Medical Policy (October 2019). https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-medical-policy
• See information from American Association of Nurse Practitioners on “State Practice Environment” at https://www.aanp.org/advocacy/state/state-practice-environment .
• Japsen B. 2017. More States Lift Patient Hurdles to Nurse Practitioners. Forbes . https://www.forbes.com/sites/brucejapsen/2017/02/24/another-state-lifts-patient-hurdles-to-nurse-practitioners/?sh=3b44ec6d5fc8
• GCP Q&A: Focus on Subinvestigators, 2021. Journal of Clinical Research Best Practices 17(5).
• U.S. Office of Good Clinical Practice. Communications regarding adverse events from March 2013, September 2014, and October 2019. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice
• Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, Procedural October 2009, Section II. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects
• See information on Shinal v. Toms, M.D., 162 A.3d 429 (2017) at https://law.justia.com/cases/pennsylvania/supreme-court/2017/31-map-2016.html .
• https://www.indianapolis-medical-malpractice-lawyer.com/medical-malpractice/informed-consent/
• https://www.revisor.mn.gov/statutes/cite/253B.04
• https://dphhs.mt.gov/assets/amdd/MSH/volumeii/patientrights/InformedConsentForTreatment.pdf
• https://codes.findlaw.com/ca/health-and-safety-code/hsc-sect-24176.html
• https://codes.findlaw.com/ca/health-and-safety-code/hsc-sect-24172.html

Steven Eric Ceh, DPM, ( [email protected] ) is a Consultant with SEC Clinical Consulting, Ltd. In Westerville, Ohio.

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• Principal Investigator Roles and Responsibilities

Position Role Sponsored Program Administration Financial Management Effort Reporting Conflicts of Interest Human Research Participant Protection Animal Welfare Environmental Health and Safety Human Gene Transfer Patents and Inventions Export Controls

Position Role

The Principal Investigator (PI) is charged to conduct objective research that generates independent, high quality, and reproducible results. The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Additionally, the Principal Investigator is responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with school, department, and central administration personnel to assure research in is conducted in accordance with federal regulations and university and sponsoring agency policies and procedures.

The Principal Investigator reports to a designated official such as a dean, department head, or division chief.

Sponsored Program Administration

General administrative.

• Coordinates with school, department, and central administration personnel to help ensure that sponsored research and related activities are in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Administers and oversees research and all related activities.
• Assures that all key personnel involved in sponsored program administration have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

• Obtains or coordinates with department administrator to obtain appropriate internal approvals and assure that proposals meet federal regulations and university and sponsoring agency policies and procedures prior to submitting proposal to sponsoring agency.

Proposal Budget

• Develops budget justification in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Makes key budgetary decisions and verifies that appropriate budgets and cost projections are prepared to deliver the proposed project scope.
• Prepares or coordinates with department administrator to prepare categorized budget and justification and confirm accuracy and completeness of budgeted costs.

Protocol Preparation and Review

• Prepares and submits scientific protocol(s) or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Submits any proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
• Reviews protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Award Acceptance (Terms and Conditions)

• Recognizes the University as the recipient of awards.
• Reviews and signs award agreement in accordance with University policies and procedures.
• Complies with and implements award terms and conditions and subcontract scope of work. Prepares or coordinates with department administrator to prepare a revised categorized budget based on the actual award and the specific needs of the project.
• Complies with terms of award acceptance in accordance with federal regulations and university and sponsoring agency policies and procedures.

Conduct of Research

• Oversees the conduct of research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Oversees the research team to help ensure ethical conduct in all aspects of the research process including but not limited to the treatment of human and animal subjects, conflicts of interest, data acquisition, management, sharing and ownership, publication practices, responsible authorship, and collaborative research and reporting.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Facilities and Administrative Cost Rate

• Identifies program type to allow determination of correct facilities and administrative (F&A) cost rate.
• Coordinates with school, department, and central administration personnel to verify that the correct F&A cost rate is applied to sponsored project budgets.

Space Management

• Uses allocated space appropriately and efficiently and reports correct use of space to the department.

Equipment Management

• Obtains, maintains, and safeguards equipment used to conduct research in accordance with federal regulations and university and sponsoring agency policies and procedures.

Service Centers

• Develops, monitors, and administers service center rates in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Provides general oversight for operation of specialized service centers in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Complies with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

• Submits accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.

Financial Management

• Oversees administration of project funds.
• Coordinates with school, department, and central administration personnel to determine whether the project charges are allowable and allocable in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Verifies the authenticity and accuracy of expended funds.
• Assures that all key personnel involved in financial management have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts related to financial management and reports instances of noncompliance to the appropriate compliance office.

Cost Sharing

• Coordinates with school, department, and central administration personnel to identify and authorize cost sharing obligations and expenditures.

Cost Transfer

• Reviews and authorizes cost transfers a timely manner in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Supervises and approves the posting of project expenses to the fund in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Coordinates with school, department, and central administration personnel to initiate resolution to any cost overruns.
• Coordinates with departmental administrator and/or Sponsored Projects Accounting (SPA) to complete and submit appropriate final closeout or transfer forms.

Effort Reporting

• Reviews, adjusts, and legally certifies the accuracy of personal activity reports (PARs) for all applicable personnel.
• Completes PARs for unavailable personnel within deadlines and in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Returns signed PARs to Sponsored Projects Accounting in accordance with University policy.
• Assures that all key personnel involved in effort reporting have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts related to effort reporting and reports instances of noncompliance to the appropriate compliance office.

Conflicts of Interest

• Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the University.
• Complies with and assures personnel comply with applicable School, University, and sponsoring agency conflict of interest policies and procedures.
• Discloses all significant financial conflicts of interest to the appropriate Disclosure Review Committee (DRC) and complies with recommended management strategies.
• Supports and endorses cooperation with University compliance and monitoring efforts related to conflicts of interest and reports instances of noncompliance to the appropriate compliance office.

Human Research Participant Protection

• Protects the rights and welfare of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assures that all key personnel involved in human research complete and comply with the required education for the protection of human participants in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Acts as liaison between the Human Research Protection Office (HRPO) and the sponsor.
• Supports and endorses cooperation with University compliance and monitoring efforts related to human participant research and reports instances of noncompliance to the appropriate compliance office.
• Performs a comprehensive review of background and scientific literature prior to preparing the scientific proposal.
• Provides or coordinates with department administrator to provide accurate human research participant approval information for all submissions and correspondence to the sponsoring agency.
• Discloses and details use of human participants in the scientific proposal.
• Verifies that the protocol and proposal for funding are identical.
• Verifies that the proposal budget provides sufficient funds for compliance with federal regulations and university and sponsoring agency policies and procedures.
• Pays research participants and/or covers their expenses as approved by the HRPO Committee.
• Prepares and submits human research protocols or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.

Informed Consent

• Prepares and maintains all documents related to the informed consent process.
• Submits informed consent documents to HRPO for review and approval.
• Completes the consent process as approved, including obtaining all on-going re-consent documentation.
• Assures accurate execution of the informed consent process.
• Verifies that protocol complies with the terms and conditions of the award and that HRPO protocol approval is in place prior to the acceptance of the award and the start of research.
• Conducts research in accordance with current, approved human studies protocol for the duration of the project.
• Adheres to all recommendations and conditions placed upon the research by HRPO for the duration of the research.
• Responds to Human Studies Research Quality Assurance / Quality Improvement (HSR QA/QI) Committee review findings and implements corrective measures suggested.

Protected Health Information

• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
• Assures that all personnel complete the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems

• Promptly reports any unanticipated problems involving risks to research participants or others to the HRPO Committee (Washington University’s IRB).
• Secures and maintains or coordinates with department administrator to secure and maintain all documentation for the study in accordance with federal regulations and university and sponsoring agency policies and procedures.

Animal Welfare

• Oversees the humane care and use of animals involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assures that all key personnel involved in animal research complete the required education for the humane care and use of animals and laboratory safety and radioactive materials in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts related to animal welfare and reports instances of noncompliance to the appropriate compliance office.
• Provides or coordinates with department administrator to provide accurate animal studies approval information for all submissions and correspondence to sponsoring agencies.
• Discloses and details use of animal subjects in the scientific proposal.
• Prepares and submits animal studies protocols or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Submits proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
• Verifies that protocol complies with the terms and conditions of the award and that Institutional Animal Care and Use Committee (IACUC) protocol approval is in place prior to acceptance of award and the start of research.
• Conducts research in accordance with current, approved animal studies protocol for the duration of the sponsored project.
• Adheres to all recommendations and conditions placed upon the study by the IACUC, Division of Comparative Medicine (DCM) veterinary staff, and other University entities as appropriate for the duration of the project.

Serious Adverse Events

• Reports serious violations of approved protocol to the IACUC particularly any that may affect animal safety.
• Secures and maintains or coordinates with the department administrator to secure and maintain all documentation for the study in accordance with federal regulations and university and sponsoring agency policies and procedures.

Environmental Health and Safety

• Adheres to all federal, state, and local regulations and university and sponsoring agency policies and procedures instituted to protect the health and safety of research participants, personnel, and the environment.
• Assures that individuals handling hazardous or regulated materials are well trained in proper safety procedures and complete the required environmental health and safety education in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Establishes and monitors or coordinates with department administrator to establish and monitor safety programs for department, center, or project in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Supports and complies with all Stop Work decisions.
• Supports and endorses cooperation with University compliance and monitoring efforts related to environmental health and safety and reports instances of noncompliance to the appropriate compliance office.
• Provides or coordinates with the department administrator to provide accurate environmental health and safety information for all submissions and correspondence to the sponsoring agency.
• Verifies that facilities and resources can be provided to adequately and safely implement the research proposal.
• Verifies that the proposal budget provides sufficient funds for compliance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Identifies hazards associated with project activities.
• Prepares and submits environmental health and safety protocols or changes in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Submits and proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
• Reviews protocol at inception and as required thereafter for completeness, accuracy, and pollution prevention and health and safety improvement opportunities.
• Verifies that protocol complies with the terms and conditions of the award and that applicable environmental health and safety protocol approvals are in place prior to acceptance of award and the start of research.
• Oversees the conduct of research in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Conducts research in accordance with current, approved environmental health and safety protocols for the duration of the project.
• Coordinates with department administrator and/or Environmental Health and Safety (EHS) to implement appropriate safety procedures and practices for the research project and to assure the availability of engineering controls and safety equipment prior to the start of the research.
• Adheres to all recommendations and conditions placed upon the research by EHS and assures that safety and compliance procedures are adhered to by all personnel for the duration of the project.
• Reports promptly all on-the-job accidents, illnesses, unlawful environmental releases, and/or potential exposures in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Takes immediate and appropriate corrective actions and implements measures to prevent future occurrences.
• Complies with technical, progress, and compliance reporting requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Submits accurate and timely closeout documents to applicable federal, state, and local agencies, university entities, and the sponsoring agency in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Complies with laboratory decommissioning and safety guideline requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Human Gene Transfer

• Adheres to all federal, state, and local regulations and university and sponsoring agency policies and procedures governing human gene transfer.
• Assures that all key personnel involved in human gene transfer research have met training requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Supports and endorses cooperation with University compliance and monitoring efforts related to human gene transfer and reports instances of noncompliance to the appropriate compliance office.
• Provides or coordinates with department administrator to provide accurate human gene transfer approval information for all submissions and correspondence to sponsoring agencies.
• Verifies that the proposal budget provides sufficient funds for compliance with federal, state, and local regulations and university and sponsoring agency policies and procedures governing human gene transfer research.
• Prepares and submits human gene transfer protocols or changes in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Submits relevant protocol information to Federal agencies as required in accordance with Federal regulations governing human gene transfer research.
• Verifies that protocol complies with the terms and conditions of the award and that appropriate human gene transfer protocol approvals are in place prior to the acceptance of the award and the start of research.
• Oversees the conduct of research in accordance with federal and state regulations and university and sponsoring agency policies and procedures governing human gene transfer research.
• Conducts research in accordance with current, approved human gene transfer protocols for the duration of the research.
• Adheres to all recommendations and conditions placed upon the research by EHS and HRPO.
• Promptly reports any unanticipated problems related to human gene transfers in accordance with federal and state regulations and university and sponsoring agency policies and procedures governing human gene transfer research.

Patents and Inventions

• Coordinates with department administrator and/or the Office of Technology Management (OTM) to disclose and report patent and invention information in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Reports all inventions promptly to OTM to assure proper patent protection.
• Coordinates with OTM on the preparation and prosecution of patents.
• Supports and endorses cooperation with University compliance and monitoring efforts related to patents and inventions and reports instances of noncompliance to the appropriate compliance office.
• Provides written confirmation of invention in accordance with federal regulations and university and sponsoring agency policies and procedures.

Export Controls

• Remains aware of and adheres to federal regulations and university policies and procedures related to export controls.
• Assures that key personnel are well trained in federal regulations and university policies and procedures related to export controls.
• Discloses international exchanges of information, items, and/or activities as requested and complies with recommended management strategies and restrictions.
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• v.20(1); Spring 2020

Investigator Responsibilities in Clinical Research

Amy k. feehan.

1 Department of Infectious Disease, Ochsner Clinic Foundation, New Orleans, LA

Julia Garcia-Diaz

2 The University of Queensland Faculty of Medicine, Ochsner Clinical School, New Orleans, LA

Background: Clinical trials are an integral part of translating new basic science research into therapeutics. It is crucial for those who run clinical trials to realize the gravity of their responsibilities as principal investigators.

Methods: This review focuses on the relevant investigator responsibilities under the Code of Federal Regulations Title 21, the contents of Form 1572, FDA inspections, and methods to improve compliance.

Results: While responsibility for day-to-day study activities can be delegated to outside entities and to study staff, a clinical principal investigator who has signed US Food and Drug Administration (FDA) Form 1572 is held responsible for noncompliance and misconduct by anyone working on the study. Depending on the infraction, consequences can range from a publicly posted warning letter by the FDA to criminal prosecution and fines or imprisonment.

Conclusion: Investigators are not only responsible for producing high-quality, meaningful, scientific research, but they are also responsible for maintaining public trust. If the principal investigator acts with integrity and provides training and oversight of employees, FDA inquiries should go smoothly. Following good clinical practice standards for clinical research will result in quality data collection and facilitate the analysis and publication process.

INTRODUCTION

More than 300,000 clinical trials were listed on clinicaltrials.gov as of July 2019, of which 79% were interventional, and more than 20,000 of these trials were actively recruiting in the United States. 1 Well-designed and properly executed clinical trials are integral to the development of new drug, device, surgical, and behavioral interventions. Healthcare facilities that conduct clinical trials can provide novel, otherwise unavailable treatments for their patients. The individual responsible for the conduct of a clinical study at a site is the principal investigator (PI). While there are many advantages to being a PI for a clinical trial, PIs are subject to numerous restrictions designed to ensure patient safety and meaningful study results. A number of regulatory documents govern investigator conduct in clinical trials in the United States, including Title 21 of the Code of Federal Regulations, the Federal Food, Drug, and Cosmetic Act (21 CFR) 2 ; the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) 3 ; and the US Food and Drug Administration (FDA) Form 1572. 4 The ICH was formed to bring together regulatory authorities and pharmaceutical companies from around the world to ensure that safe, effective, and quality-controlled medications are developed and registered efficiently. While the ICH guidelines are not law, GCP is a standard that researchers in the United States and abroad recognize and abide by. The CFR and FDA Form 1572 are legally binding in the United States. Despite these regulations and guidelines, the FDA issues hundreds of warning letters each year for noncompliance. 5

This article examines the contents of the above-mentioned documents and strategies for operating within regulatory guidelines for FDA-regulated research on investigational drugs and devices. The goal of this article is to demystify the regulations regarding PI responsibilities in clinical trials.

PRINCIPAL INVESTIGATOR OBLIGATIONS

A PI need not be a physician. Sponsors who design and pay for clinical trials (eg, pharmaceutical companies) are required by law 6 , 7 to select individuals who are qualified by training and experience to conduct a clinical trial. However, if the PI is not a physician, a qualified physician or dentist should be listed as a subinvestigator for the trial and assume responsibility for all trial-related medical or dental decisions. 8

A PI can outsource research tasks, such as analysis of blood biomarkers, to contract research organizations (businesses with specialized expertise in services that are too expensive or time-consuming to conduct in-house). However, the PI—not the contract research organization—is responsible and accountable for the research.

The PI's responsibility also includes the research staff. Staff members may perform study-related tasks, such as consenting a subject, but the FDA stipulates, “The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task.” 9 The PI is held accountable if anything goes wrong. Investigators are responsible for any breach of protocol, discrepancies in recordkeeping, or other infractions by subordinates. The concept of complete responsibility being vested in the PI is also present in the ICH international guidelines. 3 Tasks and day-to-day management of the trial may be delegated, but the investigator is responsible for ensuring that the trial is conducted compliantly and that recordkeeping is appropriate and up to date. PI responsibilities are summarized in the Table .

Summary of Investigator Requirements and Responsibilities

FDA, US Food and Drug Administration; IRB, institutional review board.

Protecting Subjects

The 1962 Kefauver-Harris Amendments increased FDA regulation of clinical trials after thousands of pregnant women in Europe, Canada, and other countries were prescribed thalidomide for nausea, resulting in widespread birth defects in their children. 10 This important tragedy served as an incentive for stringent toxicology testing and oversight of investigational new drugs. 11

Investigators are charged with protecting the rights, safety, and welfare of subjects; controlling drug storage and distribution; ensuring that informed consent is adequately obtained according to 21 CFR §50; 12 and ensuring that institutional review board (IRB) review, approval, and reporting requirements are met per 21 CFR §56. 13 Recordkeeping and retention requirements include maintaining adequate records of the disposition of the drug, histories that record all observations, and any other data relevant to the individual trial. 14 These records must be maintained for 2 years following the marketing application approval for the drug indication that was studied or 2 years after the FDA is notified that no application will be filed for the indication.

Investigators must send progress reports, safety reports, and financial disclosures to the sponsor at least annually during the trial, and a final report is due at the end of the trial as specified in 21 CFR §312.64. 15 Serious adverse events—unexpected events that are severe or life-threatening—must be reported immediately, but nonserious adverse events can be reported according to the timetable for reporting specified in the protocol. The required reports for medical devices are outlined in 21 CFR §812.150. 16 Financial disclosures to the sponsor should be updated as necessary during the investigation and for 1 year following study completion. 17 Having a significant equity interest in the sponsor, which is any stock in a non–publicly traded company or $50,000 of stock in a publicly traded company, could represent a conflict of interest for the investigator, subinvestigator, or study staff. Even if the stock is held by spouses and/or dependent children of those conducting the trial, the financial interest must be disclosed to the study sponsor. Financial disclosures should be promptly updated if they change during the study.

Completing US Food and Drug Administration Form 1572

Statement of Investigator, FDA Form 1572, is used when a sponsor and investigator initiate a new trial conducted under an investigational new drug application. Form 1572 provides the study sponsor with information about the investigator's qualifications and site-specific details. This information enables the sponsor to document that both the site and investigator are appropriate for a clinical investigation. The form includes a confirmation that the investigator acknowledges and is committed to follow pertinent FDA regulations during the study.

The sponsor must ensure that Form 1572 is completed prior to permitting an investigator to begin a study, 6 and the PI should not sign the form until he or she has a full understanding of the protocol, the potential risks as outlined in the investigational brochure (a document provided by the sponsor that details all prior experience with the investigational drug or device), and the commitments listed on the form ( Figure ).

Investigator commitments from US Food and Drug Administration Form 1572.

By signing Form 1572, the PI guarantees to personally conduct or directly supervise the study. This guarantee requires that all study personnel be informed of their obligation to strictly adhere to the protocol unless the sponsor is notified or a subject is at risk of health complications. If adverse events occur, they must be reported to the sponsor.

As stated earlier, while study staff may run day-to-day operations, ultimately, the investigator is responsible for overseeing and enforcing compliance with the protocol and ensuring that informed consent has been obtained from all subjects. 12 Additionally, appropriate IRB review, approval, and reporting must be completed according to the CFR. 13 If any unanticipated problems occur that could cause risks to a subject, they must be reported to the IRB as soon as possible. Subject safety is the priority, and reporting should occur after any immediate threats to a subject are addressed. If these problems indicate a need for changes to the protocol, the PI is required to submit the changes to the IRB for approval.

Form 1572 is not required for medical device clinical trials, but 21 CFR §812.43 7 stipulates that for these studies, PIs sign an agreement that includes the investigator's curriculum vitae; a statement of relevant experience; and a commitment to follow the protocol and all regulations, to supervise all testing of the device involving human subjects, and to ensure that informed consent is obtained, properly documented, and retained. If the PI was involved in a study that was terminated, the investigator must explain why. Finally, financial disclosures must be submitted for medical device trials and updated throughout the study if they change. 18

FOOD AND DRUG ADMINISTRATION INSPECTIONS

The FDA can conduct both announced and unannounced inspections to verify compliance with the CFR and that data submitted to the agency are accurate. Inspections may be triggered by sponsor concerns, a complaint about the conduct of a site, termination of a clinical site, or the request of an FDA review division. Additionally, the FDA may inspect a site during an ongoing clinical trial to spot check in real time that the site is running compliantly and may conduct inspections for special interest products. For example, if many sites are investigating a new drug that has caused problems such as injuries or deaths at other sites, the FDA may inspect other sites trialing the same drug. The CFR gives the FDA the authority to access, copy, and verify clinical study records. 19 , 20

Risk factors for noncompliance include poor supervision and training of study staff, lack of investigator involvement, delegation of study tasks to unqualified persons, failure to adequately protect study subjects, and an overworked PI and study staff. To determine if PI supervision is adequate, the FDA assesses (1) if the study staff are qualified to perform delegated tasks, (2) if the study staff received adequate training and explanation of the protocol, (3) if the PI's involvement is adequate and ongoing, and (4) if involved third parties and contract research organizations are adequately supervised. Thus, it is crucially important that the PI is regularly involved in the study and hires competent and qualified individuals to work on the study. By appropriately training and assigning study staff and remaining involved in the study, PIs can significantly reduce the risk of noncompliance.

If the FDA inspectors find violations made by any study staff, a warning letter will be issued to the PI and publicly displayed on the FDA website to ensure that sponsors do not unknowingly engage with offenders. 5

FDA Form 483 21 is used to notify senior management of violations at the study site. After the inspection, management and FDA inspectors will discuss each infraction to ensure that both parties understand the citation. The investigator should send a written response to the FDA within 15 business days addressing each concern. If the infractions are severe and/or not addressed appropriately or not addressed at all, the FDA can issue a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain, disqualify an investigator, pursue criminal investigation through the Office of Criminal Investigations, or pursue debarment. Disqualification procedures are outlined in 21 CFR §312.70 22 and 21 CFR §812.119 23 for repeated and deliberate noncompliance. If repeated and deliberate noncompliance is noted, the FDA will give the investigator the opportunity to explain citations informally, as well as the opportunity for a formal hearing. If the FDA rules against the investigator, the individual may be temporarily or permanently banned from participating in trials of investigational drugs or medical devices. Debarments are listed on the FDA website. 24

The Ketek case provides multiple examples of egregious clinical trial violations and problems at the FDA. Ketek (telithromycin), developed by the pharmaceutical company Sanofi-Aventis, was the first antimicrobial to circumvent macrolide resistance and was approved by the FDA in 2004 for community-acquired respiratory tract infections. After approval, however, the drug was linked to severe liver injury in dozens of patients, including 4 fatalities, prompting urgent safety warnings. 25 Two congressional investigations were conducted into the FDA actions surrounding the drug approval.

The integrity of “Study 3014” was questionable. Many of the investigators were inexperienced, and Sanofi-Aventis was paying them $400 per enrolled patient. The top-enrolling physician had more than 400 patients enrolled and was found to have entirely fabricated numerous study participants. She was prosecuted and imprisoned, and 4 other sites were criminally investigated. Despite these problems, FDA employees who were not involved in the investigation presented the drug for approval without mentioning the massive breaches of data integrity. An article by Dr David Ross outlines the timeline and details of how Ketek was approved for the market, 26 but the bottom line is that inexperienced or corrupt investigators, falsified data, and irresponsible actions by FDA managers led to inappropriate drug approval and patient deaths. In 2007, the FDA dropped two of the drug indications, limiting the antibiotic to use for community-acquired pneumonia, and myriad boxed warnings accompanied the labeling. In 2016, Sanofi-Aventis permanently discontinued the drug.

MAINTAINING COMPLIANCE

PIs who are involved in their studies and proactively improve processes are unlikely to have disciplinary action result from FDA investigations. Guidelines for PIs for maintaining compliance are as follows:

• Read all communications from the IRB and ensure that the study team is compliant with IRB requests and determinations.
• Ensure study staff are experienced and verify their credentials, but do not assume they have been adequately trained by a previous employer.
• Institute regular training and assessments for subject visits, laboratory testing, data input and handling, drug accountability, and recordkeeping.
• Ensure that the study staff have disclosed any conflicts of interest and understand the importance of doing so.
• Streamline the protocol, ensuring that it is straightforward with standardized data input, checklists, and minimal amendments.
• Keep regulatory binders up to date with current training certifications and licensure. Ensure that continuing reviews are done annually and submitted to the IRB.
• Hold weekly team meetings and make plans for disasters, emergencies, quality assurance, data safety, and data management.
• Institute study dry runs before patients are involved to ensure that no components of consenting a patient or documenting a visit are missing.
• Implement regular data input, data cleaning, and query answering to keep systemic problems from spiraling out of control. If changes are made to data, audit the trail of changes to document why data were changed and by whom.
• Determine if infractions require individual correction or if systemic changes need to be implemented to prevent similar problems from arising in the future.

Although developing standard operating procedures and conducting regular self-assessments may seem to be a great deal of superfluous work, these activities will decrease discrepancies in data collection and will ensure timely reporting of any issues.

Investigators are not only responsible for producing high-quality, meaningful, scientific research, but they are also responsible for maintaining public trust. High-profile infractions such as the Ketek study cause public distrust and patient fatalities, but even small infractions such as waiting a few weeks to input study data can lead to patient safety issues. Newcomers to clinical trials should work with an experienced mentor who can help structure standard operating procedures for trials and employee training. If a PI acts with integrity and provides training and oversight of employees, FDA inquiries should go smoothly. Regardless of governmental oversight, using GCP standards for clinical research will result in quality data collection and facilitate the analysis and publication process.

ACKNOWLEDGMENTS

The authors have no financial or proprietary interest in the subject matter of this article.

This article meets the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties Maintenance of Certification competencies for Patient Care, Medical Knowledge, and Systems-Based Practice.

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Chapter 4 - Roles and Responsibilities of Investigators and Research Staff

Book search, principal investigator.

The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process. Although the PI may delegate tasks to members of his/her research team, s/he retains the ultimate responsibility for the conduct of the study.

Who May Serve as a Principal Investigator

Because PI responsibilities involve direct interaction and supervision of the research team, the PI must be a current employee or student of the University and/or UPMC who is operating within their University or UPMC role to oversee the conduct of the study. PIs leaving the institution are responsible for notifying the IRB well in advance of their departure so that they can make arrangements to either close the study or name another appropriately qualified individual currently at the institution to serve as the PI.

The following individuals may serve as PI(s):

• Faculty members:  All categories of compensated faculty members may serve as PI if their School allows them to serve as Principal Investigator on applications for sponsored funding administered through the University.   Adjunct faculty of the University, including lecturers and instructors, are not permitted to serve as a PI or Faculty Mentor but may serve as co-investigator.  Faculty with a “visiting” title cannot serve as PI unless it is temporarily assigned during transition from another institution.
• Staff:  Other University, UPMC, or UPP staff may serve in this role if they have appropriate qualifications to conduct the research and if they have obtained approval to conduct the research from their immediate supervisor.

Note:  The IRB reviews and holds student research projects to the same standards as human subject research conducted by faculty or staff. IRB approval or exemption must be obtained prior to initiating any research activity under IRB oversight. “Retroactive” IRB approval or exemption is not permitted under federal regulations and University policy. Failure to obtain IRB approval for research with human subjects may preclude the use of the previously collected data and could result in other institutional sanctions.

​General Responsibilities of Principal Investigators

As a general condition for the approval of a research study, the IRB holds the principal investigator of the study responsible for ensuring that:

• Risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
• Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result;
• Selection of human subjects and patients for research participation is equitable;
• Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by University policies and federal regulations;
• Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by University policies and federal regulations;
• Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects;
• The privacy of human research subjects is protected and the confidentiality of data is maintained;
• Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons).

Specific Responsibilities of Principal Investigators

The IRB holds the principal investigator of an approved research study responsible for:

• Promptly responding to all requests for information or materials solicited by the IRB, including the timely submission of the research study for IRB renewal;
• Ensuring that adequate resources and facilities are available to carry out the proposed research study;
• Abstaining from enrolling any individual in a research study (i) until such study is approved in writing, by the IRB; (ii) during any period when the IRB or sponsor/principal investigator has suspended study activities; or (iii) following IRB- or sponsor/principal investigator-directed termination of the study;
• Ensuring that all associates, colleagues, and other personnel assisting in the conduct of the research study are appropriately informed of (i) the study procedures; (ii) informed consent requirements; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) reportable new information requirements; and (v) data collection and record-keeping criteria;
• Conducting the study in strict accordance with the current IRB-approved research protocol except where a change may be necessary to eliminate an apparent immediate hazard to a given human research subject;
• Reporting of deviations that meet the definitions outlined in Chapter 17 from the currently approved research protocol;
• Requesting IRB approval of any proposed modification to the research protocol or informed consent documents prior to implementing such modifications;
• Obtaining prospectively and documenting informed consent in accordance with the current IRB-approved informed consent documents (i.e., unless the IRB has granted a waiver of the consent process)
• Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation;
• Reporting promptly to the IRB (and, if applicable, the sponsor and FDA) any internal or external adverse event that is considered to be unexpected,  serious, and 3) possibly or definitely related to the study;
• Reporting promptly to the IRB any significant changes in the risk/benefit of study participation;
• Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible;
• Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study;
• Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable University required training modules;
• Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines, if applicable. If the study meets the NIH definition of a clinical trial, ensuring that all research investigators and coordinators have completed the Good Clinical Practices training required by the University IRB;
• Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.
• Complying with additional requirements for federal agencies as outlined in Chapter 26.

Responsibilities of investigators are further detailed in the references outlined below.  

• DHHS: Office of Human Research Protections (OHRP): Investigator Responsiblities FAQs
• FDA: Statement of the Investigator Form FDA 1572 FA Q [pdf]
• FDA: Guidance: Investigator Responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects [pdf]
• FDA: 21 CFR 312, Subpart D: General Responsibilities of Sponsors and Investigators: Drugs
• FDA: 21 CFR 812, Subpart E: Responsibilities of Investigators: Devices

Sub-Investigators and Research Staff

Appropriately qualified sub-investigators and research staff may perform tasks as delegated by the Principal Investigator but they do not accept primary responsibility for the research study.

General Responsibilities of the Sub-Investigator and Research Staff

• Completing required institutional and protocol specific training
• Adhering to the federal regulations, state and local laws, institutional policies and procedures surrounding the safety and protection of human participants
• Assuring participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and HRPO policies and procedures.  

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Research Investigator Job Description

A research investigator is responsible for conducting research activities involving diverse sample processing techniques. They are responsible for collecting and interpreting data and using various analytical instruments while understanding components, processes and interactions that are at the focus of the research activity. A research investigator is also responsible to compile, write and evaluate data for publication purposes.

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Education you need to become a Research Investigator

These are the most common degrees or certificates earned by Jobtrees users prior to becoming a Research Investigator

There may be other required degrees or certifications needed for this job. The below info shows you the most commonly desired education level from employers when hiring for this job.

• Master of Science (m.sc.) in Biology 2 The number of occurrences matches with Research Investigator in our database. Avg. Duration: 15 months Avg. Fees: $25,091 Type: Mostly full time View more on Studyportals
• Master of Science (m.sc.) in Pharmaceutics 1 The number of occurrences matches with Research Investigator in our database. Avg. Duration: 18 months Avg. Fees: $33,668 Type: Mostly full time View more on Studyportals
• Doctor of Philosophy (PH.D.) in Chemical Engineering 1 The number of occurrences matches with Research Investigator in our database. Avg. Duration: 40 months Avg. Fees: $31,545 Type: Mostly full time View more on Studyportals
• Bachelor of Science (b.sc.) in Public Relations 1 The number of occurrences matches with Research Investigator in our database. Avg. Duration: 48 months Avg. Fees: $30,074 Type: Mostly full time View more on Studyportals
• Bachelor of Science (b.sc.) in Biological Sciences 1 The number of occurrences matches with Research Investigator in our database. Avg. Duration: 48 months Avg. Fees: $31,407 Type: Mostly full time View more on Studyportals

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The Role and Responsibilities of a Principal Investigator

The role of a Principal Investigator (PI) is crucial in the field of research and represents a significant responsibility. PIs play a vital role in designing, implementing, and overseeing research projects, ensuring their successful completion while upholding ethical standards. This article will explore the role and responsibilities of a Principal Investigator, including their definition, key duties, skills and qualifications, challenges faced, and impact on research projects.

Understanding the Role of a Principal Investigator

A Principal Investigator, often referred to as a PI, is the primary leader and decision-maker of a research project. They take on the responsibility of directing and coordinating the research team, ensuring the project's objectives are met. PIs serve as the principal contact between the research team and external stakeholders, such as institutions, sponsors, and regulatory bodies.

The Definition of a Principal Investigator

A Principal Investigator is an individual who is granted the authority to lead and conduct a research project. They are responsible for the overall scientific and technical integrity of the project, ensuring compliance with regulations and ethical guidelines. PIs are typically employed by academic institutions, government agencies, or private organizations.

Key Duties of a Principal Investigator

As a Principal Investigator, there are several key duties that must be fulfilled. One of the primary responsibilities is developing and designing research proposals. PIs must possess strong analytical and conceptual skills to identify research gaps and develop innovative research plans. They must also have a thorough understanding of the subject matter and appropriate research methodologies.

Additionally, PIs oversee the research team, including recruiting and managing staff, assigning responsibilities, and providing guidance and supervision throughout the research process. They are responsible for establishing clear roles and expectations within the team, fostering effective communication, and promoting a collaborative work environment.

Furthermore, PIs are responsible for ensuring ethical conduct throughout the research project. This includes obtaining necessary ethics approvals, protecting the rights and confidentiality of participants, and ensuring data integrity. PIs must also actively mitigate any potential conflicts of interest that may arise during the research process.

The Principal Investigator in the Research Process

Being a Principal Investigator involves various responsibilities throughout the research process, from proposal development to project completion and dissemination of findings. This section will explore the specific roles of a PI in preparing and submitting research proposals, overseeing the research team, and ensuring ethical conduct in research.

Preparing and Submitting Research Proposals

One of the primary responsibilities of a Principal Investigator is preparing and submitting research proposals to secure funding for the project. PIs must carefully outline the objectives, methods, and expected outcomes of the research to convince funding agencies or institutions of the project's value and feasibility. They must also identify potential risks and provide contingency plans to address them.

Contract research organizations ( CROs ) often play a crucial role in assisting Principal Investigators with proposal development. CROs have expertise in constructing compelling research proposals, gathering necessary supporting documentation, and navigating the submission process. It is important for PIs to collaborate with CROs to optimize their chances of securing funding and performing high-quality research.

Overseeing the Research Team

Principal Investigators are responsible for overseeing the research team throughout the project duration. This involves recruiting and selecting qualified individuals, assigning roles and responsibilities, and managing personnel issues that may arise. PIs must foster a supportive and collaborative work environment, encouraging team members to contribute their ideas and expertise.

CROs can also play a role in supporting Principal Investigators in managing the research team. They can assist with recruiting and onboarding research staff, provide training on specialized techniques or protocols, and coordinate team meetings and communication. Collaborating with CROs allows PIs to leverage their resources and expertise to enhance the efficiency and effectiveness of the research team.

Ensuring Ethical Conduct in Research

Principal Investigators hold a critical responsibility in ensuring the ethical conduct of research. PIs must obtain the necessary approvals from ethics committees or institutional review boards, which involve a thorough review of the proposed research's ethical implications and protections for human subjects or animals, if applicable. PIs must also ensure that informed consent is obtained from participants and that their confidentiality is maintained.

CROs can provide valuable guidance to Principal Investigators in navigating the ethical requirements of research projects. They can assist in developing informed consent forms, ensuring compliance with regulatory guidelines, and facilitating ethical training for the research team. Collaborating with CROs ensures that PIs can confidently undertake research while upholding the highest ethical standards.

Skills and Qualifications of a Principal Investigator

Being a Principal Investigator requires a unique combination of skills and qualifications. While the specific requirements may vary depending on the field of research, certain fundamental qualities are essential for success. This section will explore the educational requirements and essential skills that Principal Investigators should possess.

Educational Requirements

Principal Investigators typically require a strong academic background, usually holding a doctoral degree in their respective field. A Ph.D., M.D., or equivalent terminal degree provides the necessary expertise and credibility to lead research projects. Additionally, PIs may need to have expertise in specific research methodologies or techniques relevant to their field.

Essential Skills for Success

Alongside the necessary educational qualifications, Principal Investigators must possess a range of essential skills to effectively fulfill their role. Strong communication and interpersonal skills are crucial for collaborating with the research team, stakeholders, and funding agencies. PIs should also have excellent problem-solving and critical-thinking abilities, enabling them to navigate challenges that arise during the research process.

Leadership skills are also essential for Principal Investigators. They must be able to motivate and inspire their team, foster a positive work environment, and lead by example. Additionally, PIs should have strong organizational and time management skills to coordinate multiple tasks and meet project deadlines.

CROs can provide additional support to Principal Investigators by supplementing their skillsets. CROs often have expertise in project management, data analysis, and quality assurance, which can complement the abilities of PIs. By partnering with CROs, Principal Investigators can enhance their research capabilities and overcome any skill gaps.

Challenges Faced by Principal Investigators

The role of a Principal Investigator is not without its challenges. PIs encounter various obstacles throughout the research process that can hinder their effectiveness. This section will explore two common challenges faced by Principal Investigators - balancing administrative and research duties and managing research funding and budgets.

Balancing Administrative and Research Duties

Principal Investigators often find themselves balancing administrative responsibilities with the primary task of conducting research. Administrative duties may include managing budgets, supervising staff, and fulfilling reporting and regulatory requirements. Striking a balance between these administrative duties and research-related tasks can be challenging, as both require significant time and attention.

CROs can support PIs in managing administrative duties, allowing them to focus on the core research activities. CROs can assist with budget planning, financial management, and regulatory compliance. By partnering with CROs, Principal Investigators can streamline administrative processes and allocate more time and energy to the research itself.

Managing Research Funding and Budgets

Obtaining and managing research funding is another significant challenge for Principal Investigators. Securing funding requires developing competitive proposals and navigating complex application processes. Once funded, PIs must manage budgets effectively, ensuring resources are allocated efficiently and in line with project objectives.

CROs can alleviate some of the burdens associated with managing research funding and budgets. They can provide expertise in financial management, offering guidance in budget development, cost tracking, and resource allocation. By collaborating with CROs, Principal Investigators can optimize their use of funding resources and ensure financial accountability throughout the research project.

The Impact of a Principal Investigator on a Research Project

The Principal Investigator plays a significant role in shaping the direction and outcome of a research project. Their influence extends beyond their administrative duties and encompasses leadership, team building, and research quality. This section will explore the impact of a Principal Investigator on research direction and quality, as well as their role in team building and leadership.

Influence on Research Direction and Quality

As the leader of the research project, the Principal Investigator has a direct influence on its direction and quality. PIs are responsible for defining the research objectives and designing the methodology, ensuring the project's scientific rigor. They guide the research team in executing the study and interpreting the findings, contributing to the overall quality and validity of the research.

Collaboration with CROs can significantly enhance the impact of Principal Investigators on research direction and quality. CROs often provide specialized expertise in specific research areas, offering insights into innovative methodologies, study design, and data analysis. Partnering with CROs allows Principal Investigators to tap into additional knowledge and resources to produce high-quality research.

Role in Team Building and Leadership

Principal Investigators have a fundamental role in team building and leadership within the research project. They are responsible for assembling a capable and cohesive team of researchers, fostering a collaborative work environment, and promoting professional development. Effective leadership by the Principal Investigator contributes to the team's motivation, productivity, and overall success.

Collaborating with CROs can complement the leadership efforts of Principal Investigators. CROs often have experience in facilitating team-building activities, providing training programs, and implementing performance evaluation systems. By working with CROs, Principal Investigators can access additional resources to nurture a high-performing research team.

In summary, the role and responsibilities of a Principal Investigator are integral to the success of a research project. PIs play a vital role in the design, implementation, and oversight of research, ensuring ethical conduct and scientific rigor. They face various challenges but also have the opportunity to make a significant impact on research direction, quality, and team dynamics.

By collaborating with contract research organizations (CROs), Principal Investigators can leverage additional expertise, resources, and support throughout the research process. CROs provide valuable assistance in proposal development, team management, and navigating regulatory requirements. Partnering with CROs allows PIs to optimize their research capabilities and enhance the overall effectiveness and efficiency of their projects.

If you're a Principal Investigator seeking to streamline your research project's design, implementation, and oversight, look no further than Lindus Health. Our comprehensive suite of services provides you with an all-in-one solution, from protocol writing to data delivery, including site services and an integrated eClinical platform. Embrace the ease of collaborating with a CRO that understands the intricacies of your role and responsibilities. Book a meeting with our team today and elevate the efficiency and impact of your research endeavors.

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• Investigator

How to Be Research Investigator - Job Description, Skills, and Interview Questions

• How to Become
• Job Descriptions
• Skill & Competencies
• Common Tools
• Professional Organizations

The introduction of research investigators into a project can have a significant effect on its success. Research investigators bring a wealth of knowledge and experience to the project, enabling them to analyze data, identify trends, and make data-driven decisions. They are also skilled in the use of various research methods, such as surveys, interviews, and focus groups, to collect the necessary data.

Their insights can be invaluable in developing strategies to tackle any challenges that arise. Furthermore, their presence can bring credibility to a project, as research investigators are usually affiliated with a reputable institution or organization. This can help to attract additional funding, resources, and support for the project.

Steps How to Become

• Earn a Bachelor's Degree. The first step to becoming a research investigator is to earn a bachelor's degree in a scientific field, such as biology, chemistry, psychology, or physics. This should include courses in the scientific method, research design, and statistics.
• Earn a Master's Degree. After completing a bachelor's degree program, you may choose to pursue a master's degree in a research-focused field. In addition to coursework, you may be required to complete a research project and write a thesis.
• Gain Relevant Experience. Another important step to becoming a research investigator is to gain relevant experience. This may include working as an intern or volunteer in a research laboratory, or working as a lab assistant or technician.
• Obtain Professional Certification. Depending on the type of research you plan to do, you may need to obtain professional certification or licensure. For example, if you plan to work in a clinical setting, you may need to obtain a license to practice medicine.
• Pursue Doctoral Degree. To become a research investigator, many employers require applicants to have a doctoral degree in their field of research. This degree typically takes three to five years to complete and requires the completion of coursework, exams, and a dissertation.
• Apply for Positions. Once you have earned your doctoral degree, you can begin applying for research investigator positions. You may need to submit a resume, cover letter, and other materials such as writing samples or references.
• Keep Up with Research Trends. It is important for research investigators to stay up-to-date on the latest research trends. This allows them to be more effective in their work and develop new strategies for conducting research. Research investigators should also attend conferences and workshops to learn about new developments in their field.

Staying ahead and qualified in today's competitive landscape requires hard work and dedication. Investing in continual education and training is key to staying ahead of the curve. Not only does it help keep skills sharp and up-to-date, but it also proves that one is committed to staying abreast of new developments in the field.

networking with peers and colleagues can provide insight into emerging trends and open up potential opportunities. By taking the initiative to stay informed through research and actively participate in industry events, one can position themselves at the forefront of their field and gain the recognition they deserve.

You may want to check Investigating Officer , Professional Background Investigator , and Legal Research Investigator for alternative.

Job Description

• Clinical Research Investigator
• Regulatory Affairs Investigator
• Clinical Research Coordinator
• Data Analyst Investigator
• Quality Control Investigator
• Compliance Investigator
• Research Analyst Investigator
• Research Scientist
• Clinical Research Manager
• Clinical Research Associate

Skills and Competencies to Have

• Strong research and analytical skills
• Excellent communication and writing skills
• Ability to synthesize complex data into meaningful conclusions
• A keen eye for detail
• Familiarity with research methodology, data analysis, and statistical software
• Strong problem solving skills
• Ability to work independently and collaboratively
• Ability to work under tight deadlines
• Knowledge of relevant ethical standards and regulations
• Ability to develop innovative research designs and approaches

Having good research skills is essential for any investigator. It involves the ability to identify, analyze and interpret data and information, and to draw meaningful conclusions. Research skills involve gathering, organizing, and analyzing information, as well as being able to effectively communicate the results of that research.

A good investigator must have strong research skills, as it is an important part of the job. Without these skills, it would be difficult for them to find evidence and create a case. Research investigators must also be able to make connections between facts, and understand how different pieces of evidence are related to one another.

They must also have good problem solving skills in order to be able to find solutions to complex problems. they should be able to clearly communicate their findings in a way that is easy for others to understand. having strong research skills is essential for any investigator, as it provides them with the necessary tools to successfully do their job.

Private Investigator , Loss Prevention Investigator , and Title Abstractor/Investigator are related jobs you may like.

Frequent Interview Questions

• What experience do you have in research investigation?
• What methods do you use to gather evidence and analyze data?
• How do you stay up-to-date on developments in the field?
• Describe a complex research project you have completed.
• What techniques do you use to ensure accuracy and reliability of your results?
• How do you handle ambiguity when conducting research?
• What challenges have you faced when working with limited resources?
• How do you make decisions when multiple hypotheses are possible?
• Describe a difficult situation where you had to gather and interpret data quickly.
• How have you used technology to enhance your research process?

Common Tools in Industry

• Qualtrics. Qualtrics is an online survey and data collection software that allows researchers to easily create surveys, distribute them, and analyze the collected data. (e. g. Qualtrics was used to survey participants in a study about customer satisfaction. )
• R-Studio. R-Studio is a data analysis software used for statistical computing and graphics. It can be used to analyze survey data, create visualizations of results, and generate reports. (e. g. R-Studio was used to analyze survey results from a study on public opinion. )
• SPSS. SPSS is a statistical software package used for data analysis, predictive analytics, and data mining. It can be used to analyze survey data and generate reports. (e. g. SPSS was used to analyze survey results from a study on customer preferences. )
• NVivo. NVivo is an advanced qualitative data analysis software used to analyze large amounts of unstructured data such as surveys, interviews, focus groups, and other forms of qualitative data. (e. g. NVivo was used to analyze interviews from a study on employee satisfaction. )
• Atlas. ti. Atlas. ti is a qualitative data analysis software used to analyze unstructured data from various sources such as surveys, interviews, focus groups, and other forms of qualitative data. (e. g. Atlas. ti was used to analyze survey results from a study on customer experience. )

Professional Organizations to Know

• Association of American Medical Colleges (AAMC)
• American Association for the Advancement of Science (AAAS)
• American Society for Clinical Investigation (ASCI)
• American College of Physicians (ACP)
• National Institutes of Health (NIH)
• American Academy of Pediatrics (AAP)
• American College of Surgeons (ACS)
• Society for Research in Child Development (SRCD)
• Federation of American Societies for Experimental Biology (FASEB)
• Infectious Diseases Society of America (IDSA)

We also have Corporate Investigator , Intelligence Analyst/Investigator , and Professional Investigator jobs reports.

Common Important Terms

• Protocol. A protocol is a set of rules and standards that govern how a study should be conducted. Protocols provide guidance on how to conduct research activities such as data collection, data analysis, and reporting.
• Research Design. A research design is the overall plan for carrying out a study. It describes the goals of the study, how data will be collected and analyzed, and how results will be interpreted.
• Data Analysis. Data analysis is the process of examining, cleaning, transforming, and modeling data with the goal of discovering useful information, suggesting conclusions, and supporting decision-making.
• Literature Review. A literature review is a systematic survey of published material on a given topic. It is used to identify gaps in the existing research and to provide an overview of what is already known about the topic.
• Ethical Guidelines. Ethical guidelines are a set of principles and rules that govern the conduct of research. They provide guidance on how to treat research participants and how to protect their rights and safety.

Frequently Asked Questions

What is a research investigator.

A Research Investigator is an individual who is responsible for conducting research and investigations into a particular subject matter.

What qualifications are required to become a Research Investigator?

To become a Research Investigator, one must typically possess at least a Bachelor's degree in a relevant field, such as criminal justice, psychology, sociology, or another related area. Additionally, many employers require research investigators to have at least two years of experience in the field.

What duties does a Research Investigator typically perform?

A Research Investigator typically performs a variety of tasks, including conducting interviews, collecting evidence, analyzing data, preparing reports, and making recommendations based on their findings.

What type of environment does a Research Investigator typically work in?

Research Investigators typically work in a variety of environments, from offices to courtrooms to crime scenes. They may also conduct research remotely or in the field.

Is it possible to become a Research Investigator without a degree?

It is possible to become a Research Investigator without a degree, but it is highly unlikely. Most employers prefer to hire individuals with a Bachelor's degree in a relevant field such as criminal justice, psychology, sociology, or another related area.

What are jobs related with Research Investigator?

• Digital Media Investigator
• Analytical Investigator
• Criminal Investigator
• Forensic Investigator
• Special Investigator
• Corporate Security Investigator
• Internal Investigator
• Insurance Claims Investigator
• Assigned Investigator

Web Resources

• RESEARCH INVESTIGATOR | U-M Careers careers.umich.edu
• Chapter 4 - Roles and Responsibilities of Investigators www.hrpo.pitt.edu

Clinical Research Coord I

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Sr. Research Investigator (Department of Translational Medicine and Human Genetics)

• University of Pennsylvania
• Philadelphia, PA, USA
• Sep 13, 2024

Job Description

• Design and ensure successful execution of experiments while working cross-functionally with team members, collaborators, core labs and resources.
• Perform imaging-based experiments including high-dimensional immunofluorescence and other tissue-based assays, and others as needed.
• Support with training, supervising, and mentorship of laboratory personnel, graduate students, and scientific collaborators. This duty includes troubleshooting projects both independently and as part of a team within specified timelines.
• Contribute to the data management, advanced analytics, interpretation, presentation, and manuscript writing/development for peer-reviewed publication for laboratory studies led by the CSTL and Fajgenbaum Lab.
• Collaborate closely with the Principal Investigator and Associate Director of Immunology to identify key research questions, conceptualize/design scientific studies to address them, support grant writing, engage key collaborators, and write and submit reports and publish findings in high-impact peer-reviewed journals.
• Emerge as a technical/scientific subject matter expert for the assigned scientific discipline/disease area of cytokine storms
• Participate in and present at scientific meetings and conferences.
• Review, edit, format, and support manuscripts for publication and of grant proposals
• Other duties and responsibilities as assigned
• PhD/MD/DVM and 5 to 7 years of postdoctoral experience required. Experience in Immunology, Hematology, Microbiology, Cell & Molecular Biology, Cancer Biology, or related field with knowledge of immunology or related field with knowledge of immunology required.
• Direct experience performing microscopy and imaging techniques required
• Strong, proven supervisory and management experience desirable
• Experience with human biology, immunology, or hematology desirable
• Experience studying inflammatory, hyper-cytokine states or lymphoproliferative disorders desirable
• Experience working with cell lines and animal models a plus
• Excellent organizational and time management skills
• Self-starter with a strong desire to contribute and work collaboratively to achieve goals.
• Ability to work independently and apply critical thinking and sound judgment
• Ability to work with and take a leadership role in a multi-disciplinary team
• Ability to perform high-level report writing and presentation skills
• Ability to communicate effectively with team members
• Excellent oral/written communication skills with exceptional attention to detail.
• Strong computer/technology skills including QuPath or other imaging analysis software, FlowJo, Prism, and MS PowerPoint.
• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

Application Details (to apply use the Apply Now button below.)

How to Apply: Please click the "Apply Now" button below or visit: https://wd1.myworkdaysite.com/recruiting/upenn/careers-at-penn

Jobs at the University of Pennsylvania. When inquiring or applying for positions within the University of Pennsylvania, please also reference AcademicCareers.com

Applicants with dual-career considerations can find university jobs such as professor jobs, dean jobs, chair / department head jobs, and other faculty jobs and professional and administrative staff employment opportunities at the University of Pennsylvania and at other institutions of higher education in the region on www.AcademicCareers.com To receive email alerts when new jobs at the University of Pennsylvania are posted, job seekers can sign up at new job openings at the University of Pennsylvania.

A Great Place to Work

Penn's innovative schools, centers, and divisions offer a vast array of positions in a broad range of fields. Penn is the largest private employer in Philadelphia. Here you can find new opportunities as your career develops—from your first job out of school to your first leadership role, and all points in between. You can discover new work settings as your goals evolve, and even change professions.

We’re famous for research and education, but did you know Penn also offers positions in areas such as financial management, hospitality, transportation, real estate development, investments, public safety, fundraising, marketing, communications, and information technology (IT)?

Penn is a leading employer in key fields. We are regularly ranked as one of the best places to work in IT, and our Office of Development and Alumni Relations is one of the premier organizations in the industry.

If you have a passion for excellence in education, research, or service to the community, Penn is the right choice for any point in your professional journey.

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

When inquiring or applying for positions within the University of Pennsylvania, please also reference AcademicCareers.com

Staff Research Associate - 132160

Job description, #132160 staff research associate.

UCSD Layoff from Career Appointment : Apply by 9/14/24 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants : Apply by 9/25/24. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Staff Research Associate will carry out research under the direction of the Principal Investigator (PI) on lung development, regeneration, aging and disease in the mouse. Incumbent will manage lab flow cytometry and cell sorting capabilities; run fluorescence-activated cell sort (FACS) and ex vivo 3D co-culture assays in the evaluation and fibroblast contribution to epithelial progenitor growth and differentiation.

Incumbent will also operate and perform standard studies on a FACS for various PIs (Principal Investigators) within the Division of Biological Sciences. Additionally, incumbent will generate data, analyze results, and present results at lab meetings. This position is also responsible for organizing and maintaining the lab, monitoring lab expenditures, and serves as lab biohazard and safety coordinator. Incumbent will train and manage undergraduate research assistants and assist others in their experiments. Perform other duties as assigned.

QUALIFICATIONS

Experience working with infectious agents of BL2/BL2+ using in vivo models.

Theoretical and practical knowledge of biochemistry, molecular biology, immunology and genetics, including relevant laboratory techniques, acquired through a BS in Biology or related field OR an equivalent combination of education and laboratory experience.

Proven ability to independently participate in the execution of research projects or portions of such projects, independently planning, organizing and performing experiments and selecting data for analysis.

Experience in sterile technique for the propagation of prokaryotic and mammalian cells.

Extensive knowledge of specialized scientific terminology relating to topics of molecular biology, cell biology and animal physiology.

Experience working with mice as research model system, including experience genotyping, maintaining mouse lines, and performing surgery and dissection.

Proven ability to utilize scientific literature and apply to a research project. Experience conducting scientific literature searches, including online databases and other resources.

Ability to develop, follow and troubleshoot established lab protocols and lab procedures with direction from PI.

Excellent organizational skills including the ability to keep clear and accurate records, organize a varied workload, follow written and oral protocols and give oral presentations on the progress of research in lab meetings. Proven ability to prioritize and schedule experiments and duties to maximize efficiency.

Excellent interpersonal communication skills to interact well with others to facilitate communication about lab requirements including the ability to discuss and understand day-to-day laboratory affairs, research plans, results and ideas with PI and other lab personnel in a constructive, professional and pleasant manner.

Familiarity with Apple and PC computers and associated word processing and spreadsheet software with a willingness and ability to update and increase skills and knowledge as needed.

Demonstrated ability to hire and manage undergraduate student employees. Skill to train others in various lab techniques and procedures (safety precautions, preparation of media, dishwashing, equipment usage. laboratory maintenance, etc.).

Knowledge/understanding and at least some experience with Safety Data Sheets, hazard communication and Injury and Illness Prevention Program. Familiarity with a Chemical Hygiene Plan addressing safety precautions including appropriate clothing and shoes, safe handling of chemicals, use of protective items. Willingness and ability to keep safety training current and consistent with research involvement.

Experience and knowledge of proper handling, storage and disposal of chemicals, biochemicals, hazardous chemicals, and biohazardous materials including radioactive materials.

Willingness and demonstrated ability to embrace and consistently uphold the principles of community for a collaborative work environment.

Knowledge of laws and regulations that govern the housing and management of laboratory animals as applied to the University of California. Sensitivity to the needs of caged laboratory animals in compliance with AAALAC standards.

Skill and knowledge to proactively maintain an organized lab and stocks of essential supplies and media, purchase new equipment, and ensure lab equipment is operating effectively.

Ability to maintain confidentiality in matters related to work.

SPECIAL CONDITIONS

Must be willing to work with mice and be comfortable with the use of mice as experimental animals.

Must be willing and able to work safely with BL2 level viral and known carcinogens used for gene activation.

Must be willing to use various lung injury models.

Background check required.

Flexible work schedule required. Willingness and ability to work occasional evenings and/weekends as required by the needs to the research project(s).

Must be able to work on feet all day and willing and able to safely lift mouse cages.

Pay Transparency Act

Annual Full Pay Range: $55,374 - $66,064 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $26.52 - $31.64

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community .

UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20 For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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Posted : 9/11/2024

Job Reference # : 132160

JOIN OUR TALENT COMMUNITY

Interested in working at UC San Diego and UC San Diego Health but can't find a position that's right for you? Submit your resume to our Talent Community to be considered for future opportunities that may align with your expertise. Please note, by joining our Talent Community, you are not applying for a position with UC San Diego Campus and Health. Rather, this is an additional way for our Talent Acquisition team to find candidates with specific credentials, if an opportunity arises. You are still encouraged to regularly check back on our career site or sign up for Job Alerts to apply for openings that are a match for your background.

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Job Description

Senior Research Investigator job description

Example senior research investigator requirements on a job description.

• Ph.D. in a relevant scientific field
• Minimum of 7 years of experience in research and development
• Expertise in designing and executing experiments
• Strong analytical skills and ability to interpret complex data
• Experience in managing a team of researchers and leading projects
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Demonstrated leadership and project management skills
• Ability to prioritize tasks and manage multiple projects simultaneously
• Strong problem-solving and critical thinking skills

Senior Research Investigator job description example 1

Irobot senior research investigator job description, senior research investigator job description example 2, the international council on clean transportation senior research investigator job description.

The International Council on Clean Transportation (ICCT) is an award-winning, independent, global, non-profit research organization that provides data-driven research to policies to reduce the health and environmental impacts of the transportation sector. The ICCT offers a mission-driven and culturally diverse workplace where intelligence, flexibility, transparency, and good humor are highly valued. Join our team of more than 100 talented researchers and operations staff with offices in Washington D.C., San Francisco, Berlin, Beijing, and São Paulo.

The ICCT is looking for an enthusiastic Senior Researcher to join the organization’s Passenger Vehicles Program team with a focus on the United States. You will contribute to ICCT’s efforts to reduce the greenhouse gas emissions and drive electrification of the U.S. passenger vehicle fleet. You will contribute to a campaign on decarbonizing vehicle manufacturing supply chains and grow our wide-ranging research on vehicle technology, charging infrastructure, and associated policies. You will be based in either our San Francisco, CA or Washington, D.C. offices. You will report to our United States Program Director.

• Develop and lead complex projects, including collaborations with multiple ICCT team members and external partners
• Lead technical research on the embedded carbon in passenger vehicle supply chains
• Lead policy-relevant research projects on electrification and passenger vehicle efficiency
• Lead the development of comprehensive strategies to influence specific policies on passenger vehicles.
• Collect data and maintain databases on vehicle technology
• Conduct rigorous data and policy analysis
• Write reports, blogs, and other materials for publication
• Organize outreach activities, such as briefings, meetings, and workshops
• Engage directly with policymakers and external stakeholders
• Supervise and mentor ICCT interns and fellows
• Manage other ICCT staff on collaborative projects
• M.S. or Ph.D. in engineering, environmental science or policy, transportation, or related field
• 5+ years of applicable research experience
• Ability to conduct technical analysis and write concise reports for a variety of audiences
• Demonstrated skills in data collection, research, analytical methods, and drawing conclusions from analytical research
• Strong English communication skills, both written and verbal
• Superior proficiency with MS Office and applicable data collection and analysis software

Our Benefits:

This full-time position will be based in our San Francisco, or Washington, D.C. office. Your salary will be $100,400 (DC) or $110,400 (San Francisco). We offer an excellent benefits package, including hybrid/remote flexibilities, health insurance, substantial paid vacation, retirement contribution with generous 7% employer contribution, transportation subsidies, and other benefits.

Application:

Please submit a cover letter, resume, two relevant research reports primarily written by the applicant (links to other applicable reports within your resume are also welcome).

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Senior Research Investigator job description example 3

Netflix senior research investigator job description, resources for employers posting senior research investigator jobs.

Senior Research Investigator job description FAQs

What are the most common skills on a job description for a senior research investigator, what does a senior research investigator do.

Updated March 14, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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