project coordinator in clinical research

• Clinical Research Coordinator Roles and Responsibilities

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

Position Role

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.

Sponsored Program Administration

General administrative.

• Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to)  protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

• Assists the PI in study feasibility assessments as requested.

Proposal Budget

• Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.

Protocol Preparation & Review

• Reviews and comprehends the protocol.
• Attends investigator meetings as required or requested by the PI.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
• Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

Conduct of Research

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Registers participants to the appropriate coordinating center (if multi-site study).
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
• Coordinates participant tests and procedures.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements and university policies and procedures.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
• 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.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.

Project Closeout

• Assists the Principal Investigator in submission of 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.
• Arranges secure storage of study documents that will be maintained according to university policy or for the contracted length of time, whichever is longer.

Financial Management

• Reviews and accepts/corrects the billing matrix as set up by the Center for Applied Research Science (CARS) to facilitate billing of study procedures to the appropriate research fund.
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with university policies and procedures.

Effort Reporting

• Reviews, adjusts and legally certifies personnel activity reports if applicable. Completes effort reporting certification within the timeframe specified by Sponsored Project Accounting.

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 applicable school, university, and sponsoring agency conflict of interest policies and procedures. Discloses all financial conflicts of interest to the appropriate supervisor.
• Cooperates 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

• Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Informed Consent

• Assists in preparation of all documents related to the informed consent process.
• Assists Principal Investigator in preparation and submission of informed consent documents to HRPO for review and approval.
• Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Retains all study records in accordance with sponsor requirements and University policies and procedures.
• Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

Protected Health Information

• Adheres to and supports all Federal regulations and University policies and procedures instituted to safeguard protected health information (PHI).
• Completes 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. Assists PI to assure that all personnel complete appropriate training.
• Cooperates 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

• Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO (Washington University’s IRB).
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Environmental Health and Safety

• Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Works with Environmental Health and Safety to ensure that all facilities used are in compliance with all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.

Human Gene Transfer

• Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with Federal regulations and University and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to)  protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
• Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Engages participants in the informed consent process according to the HRPO approved process.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions.  Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and university policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
• Completes 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. Assists PI to assure that all personnel complete appropriate training.
• Cooperates with university compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Export Controls

• Develops awareness of export control regulations and complies as appropriate.

Revised January 2009 | Created 2007

• Vice Chancellor for Research
• Annual Report & Metrics
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• Chancellor Roles and Responsibilities
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• Division of Comparative Medicine Roles and Responsibilities
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Project Coordinator, Clinical Research

Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. We're looking for a Project Coordinator to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care? What You'll Do

• Become an expert on Flatiron's product offerings and provide users with product support on technical, operational, and user/account-related issues, on the phone, via e-mail and/or in person
• Support multiple projects with a focus on delivery of the scope on time, within budget and with a high-quality outcome
• Support Professional Services in their project delivery needs and ensure that all study deliverables are tracked and study documentation is current
• Support Professional Services and Finance by helping monitor project financials, budget tracking and accuracy of invoicing
• Support Professional Services in the creation and maintenance of accurate and current study documentation
• Support Professional Services in raising tasks and product requests to other departments
• Capture minutes/action items during client and internal status meetings
• Support Professional Services with problem/issue tracking and work with the PM/Others to ensure timely resolution
• Provide proactive communication with all stakeholders
• 11:00AM-8:00PM EDT
• Our Support team works holidays on a voluntary or rotational basis

Who You Are You're a proactive Professional Services professional withat least 2 years of experience. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You're a kind, passionate, and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.

• You have a good understanding of clinical research (clinic or hospital setting, pharma, and/or biotech sectors) and are eager to learn more about the digital solutions that support clinical research
• You have excellent verbal/written communication and organizational skills
• You have excellent computer skills, public speaking, presentation and teaching skills
• You are proficient with MS Office suite, Word, Excel and PowerPoint and Google Suite products
• You are self-motivated, able to work with remote teams and able to assume responsibility in a professional manner
• You have the ability to work within cross-functional team and manage multiple simultaneous projects
• You are passionate about our mission to improve healthcare through technology
• You share our commitments to diversity, inclusion, and belonging; You are excited to use your skills to optimize quality in new and innovative ways

If this sounds like you, you'll fit right in at Flatiron. Extra Credit

• You have direct experience with research regulations
• You have worked for a technology company (or have worked directly with software developers)
• You have oncology and/or clinical technology user experience

Where you'll work In this hybrid role, you'll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website. Job Compensation Range Salary Range: $61,600.00 - $92,400.00 Preferred Primary Location: Raleigh-Durham Office The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.

What are Flatiron Health Perks + Benefits

We offer a full range of benefits to support our employees and their families. These benefits include health and wellness, family planning, financial planning and time away. Additionally, we offer a variety of day-to-day perks and benefits that foster an inclusive culture, nurture our community and invest in each team member’s professional development.

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The Role of a Clinical Research Coordinator

Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC). As a CRC, you serve as the linchpin between researchers, study participants, and regulatory bodies.

In this comprehensive guide, we will explore the responsibilities, qualifications, challenges, and rewards of being a Clinical Research Coordinator. Whether you are considering a career in clinical research or already working in the field, this article provides valuable insights to help you succeed.

Responsibilities of a Clinical Research Coordinator

As a Clinical Research Coordinator, your responsibilities are diverse and demanding. You serve as the primary point of contact for study participants, ensuring their safety and well-being throughout the research process. You are responsible for recruiting and enrolling eligible participants, obtaining informed consent, and collecting accurate data. Additionally, you must adhere to strict regulatory guidelines and Good Clinical Practice ( GCP ) standards to ensure the integrity and validity of the study results. 

Monitoring participants' progress, managing adverse events, and maintaining detailed records are also crucial aspects of your role as a CRC. To effectively carry out these responsibilities, strong organizational and communication skills are essential. You must be able to multitask, prioritize, and work well under pressure. Attention to detail is paramount, as any errors or oversights can compromise the validity of the study. As a CRC, you are also expected to stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study.

Qualifications and Education Required to Become a Clinical Research Coordinator

While specific qualifications may vary depending on the institution or organization, a minimum educational requirement for most Clinical Research Coordinator positions is a bachelor's degree in a relevant field such as life sciences, nursing, or pharmacy. A solid foundation in biological sciences and research methodologies is crucial to understanding the complexities of clinical research. A master's degree in clinical research or a related field can further enhance your qualifications and open up opportunities for career advancement. 

Apart from formal education, relevant work experience is highly valued in the field of clinical research. Prior experience in a research setting, such as working as a research assistant or in a healthcare role, can provide valuable insight into the research process and make you a more competitive candidate. Additionally, possessing knowledge of regulatory guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH-GCP ) guidelines, is advantageous.

Certification Options for Clinical Research Coordinators

While certification is not always mandatory, obtaining a certification as a Clinical Research Coordinator can enhance your professional credibility and increase your job prospects. Several organizations offer certification programs for CRCs, such as the Association of Clinical Research Professionals ( ACRP ) and the Society of Clinical Research Associates ( SoCRA ). To obtain certification, you typically need to meet certain eligibility criteria, which may include a combination of education, work experience, and passing a certification exam. 

These certification programs cover a wide range of topics, including research ethics, study design, data management, and regulatory compliance. By obtaining certification, you demonstrate your commitment to maintaining high standards of practice and staying up-to-date with industry best practices.

Tips for Creating an Effective Clinical Research Coordinator Resume

In a competitive job market, a well-crafted resume can make all the difference in securing a Clinical Research Coordinator position. Here are some tips to help you create an effective resume that highlights your skills and qualifications: 

1. Start with a compelling summary: Begin your resume with a concise summary that highlights your relevant experience, qualifications, and career goals. This section should grab the attention of potential employers and encourage them to read further. 

2. Emphasize your research experience: Highlight your research experience, including any previous roles as a research assistant or involvement in clinical trials. Describe your responsibilities, methodologies used, and any noteworthy achievements. 

3. Showcase your knowledge of regulations and guidelines: Demonstrate your familiarity with regulatory guidelines, such as ICH-GCP, and any additional certifications you have obtained. This shows your commitment to ethical research practices and compliance. 

4. Highlight your organizational and communication skills: As a CRC, strong organizational and communication skills are crucial. Provide examples of how you have effectively managed multiple tasks, coordinated with various stakeholders, and maintained accurate documentation. 

5. Include relevant technical skills: Depending on the specific requirements of the position, include any relevant technical skills such as proficiency in electronic data capture systems, statistical software, or data analysis tools. These skills can set you apart from other candidates. 

Remember to tailor your resume to each specific job application, focusing on the skills and qualifications that are most relevant to the position. Proofread your resume carefully to ensure it is error-free and presents you in the best possible light.

Common Interview Questions for Clinical Research Coordinator Positions

Preparing for a job interview is essential to present yourself confidently and effectively. Here are some common interview questions for Clinical Research Coordinator positions, along with tips on how to answer them: 

1. Tell us about your experience in clinical research: Be prepared to discuss your previous roles and responsibilities in clinical research, emphasizing your ability to manage study participants, collect accurate data, and ensure compliance with regulatory guidelines. 

2. How do you handle challenges in clinical research?: Demonstrate your problem-solving skills by sharing examples of challenging situations you have encountered and how you successfully resolved them. Emphasize your ability to adapt to unexpected circumstances and maintain a high level of professionalism. 

3. How do you ensure participant safety and informed consent?: Highlight your understanding of the importance of participant safety and informed consent in clinical research. Explain your approach to obtaining and documenting informed consent, as well as your strategies for monitoring participant well-being. 

4. How do you manage time and prioritize tasks?: Showcase your organizational and time management skills by describing how you handle multiple tasks, prioritize responsibilities, and meet deadlines. Provide examples of how you have effectively managed your workload in previous roles. 

5. What are your strategies for maintaining accurate and detailed documentation?: Stress the importance of accurate documentation in clinical research and describe your methods for ensuring meticulous record-keeping. Discuss your attention to detail and your ability to maintain confidentiality. 

Remember to practice your responses to these questions beforehand, focusing on providing concise and well-thought-out answers. Also, prepare questions to ask the interviewer to demonstrate your interest in the role and organization.

Challenges and Rewards of Being a Clinical Research Coordinator

Working as a Clinical Research Coordinator comes with its own set of challenges and rewards. It is essential to be aware of both aspects to make an informed decision about pursuing a career in this field. 

Challenges: 

1. Time management: Balancing multiple tasks and deadlines can be challenging, especially when working on multiple studies simultaneously. Strong organizational skills and the ability to prioritize effectively are crucial. 

2. Regulatory compliance: Adhering to strict regulatory guidelines and ensuring compliance with ethical standards can be complex. Staying updated on the latest regulations and guidelines is essential to avoid any non-compliance issues. 

3. Participant recruitment: Recruiting and enrolling eligible participants can be challenging, particularly when dealing with specific inclusion and exclusion criteria. A proactive and strategic approach to participant recruitment is necessary. 

Rewards: 

1. Contribution to medical advancements: As a Clinical Research Coordinator, you play a vital role in advancing medical knowledge and improving patient care. The data and insights you collect contribute to the development of new treatments and therapies. 

2. Personal and professional growth: Working in clinical research provides continuous opportunities for learning and professional development. You gain valuable experience in research methodologies, data management, and regulatory compliance. 

3. Making a difference: By ensuring participant safety and well-being, you make a meaningful impact on the lives of study participants. Clinical research coordinators are instrumental in bringing new treatments and therapies to patients in need. 

The challenges and rewards of being a Clinical Research Coordinator often go hand in hand. The satisfaction of overcoming challenges and contributing to medical advancements can be immensely rewarding and fulfilling.

Continuing Education and Professional Development Opportunities 

Continuing education and professional development are crucial for Clinical Research Coordinators to stay updated on the latest research methodologies, regulations, and best practices. Here are some opportunities for ongoing learning and growth: 

1. Workshops and conferences: Attend workshops and conferences related to clinical research to expand your knowledge, network with industry professionals, and stay informed about the latest advancements in the field. 

2. Online courses and webinars: Take advantage of online courses and webinars offered by reputable organizations and institutions. These courses cover a wide range of topics, from research ethics to data analysis. 

3. Association membership: Join professional associations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates ( SoCRA ). These associations offer resources, networking opportunities, and certification programs. 

4. Advanced degrees: Consider pursuing an advanced degree, such as a master's or doctoral degree, in clinical research or a related field. This can provide in-depth knowledge and open up opportunities for leadership roles in the field. 

Continuing education not only enhances your skills and knowledge but also demonstrates your commitment to professional growth and maintaining high standards of practice.

Resources and Associations 

As a Clinical Research Coordinator, it is essential to stay connected with the wider clinical research community and have access to valuable resources. Here are some notable associations and resources for CRCs: 

1. Association of Clinical Research Professionals ( ACRP ): ACRP is a global membership association that provides educational resources, networking opportunities, and certification programs for clinical research professionals. 

2. Society of Clinical Research Associates ( SoCRA ): SoCRA offers certification programs, training resources, and networking opportunities for clinical research professionals. They also publish a quarterly journal, "The Monitor," which provides valuable insights and updates in the field. 

3. ClinicalTrials.gov : ClinicalTrials.gov is a public database maintained by the U.S. National Library of Medicine. It provides information on clinical trials worldwide, allowing CRCs to stay updated on ongoing and upcoming studies. 

4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ): The ICH website provides access to guidelines and standards for the conduct of clinical research. Familiarize yourself with these guidelines to ensure compliance and ethical conduct. 

By utilizing these resources and actively engaging with professional associations, you can stay informed about the latest industry developments, connect with peers, and access valuable tools and support.

The role of a Clinical Research Coordinator is diverse, demanding, and rewarding. As a CRC, you play a crucial role in advancing medical knowledge, ensuring participant safety, and contributing to the development of new treatments and therapies. By understanding the responsibilities, qualifications, and challenges of the role, you can position yourself for success in the field of clinical research. 

Continuously seek opportunities for professional growth, stay updated on the latest regulations and best practices, and actively engage with the clinical research community. With dedication, passion, and a commitment to excellence, you can thrive as a Clinical Research Coordinator and make a significant impact in the field of clinical research.

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Project Coordinator – Clinical Research (Hybrid)

We are seeking a talented, detail-oriented, and highly motivated Project Coordinator to support clinical department research activities. The Project Coordinator will be involved in study coordination, data collection, data management, and analysis. The ideal candidate will collect agenda items, coordinate research team meetings, and track action items for the team. They will have strong analytical skills and the ability to prepare data tables and figures, study schematic and model overview images, conference posters, podium presentations, and reference libraries with minimal oversight by the PIs and Supervisor. The ideal candidate will have strong writing skills, enabling their contribution to high quality written materials ready for inclusion in grant applications and publications, and the Program Coordinator will assist with both Internal Review Board (IRB) application and manuscript submission workflows. The coordinator/writer will report to the Director of OSA (Scientific Affairs) with priorities set by the Clinical Department Chair/PI funding the position.

As a successful candidate, you will:

• Coordinate and facilitate the daily operations of projects; plan and implement research activities, including team meetings, setting agendas and following up on action items; interact closely with multiple study team members, providing project updates as needed.
• Collect, manage, and analyze research data; prepare data tables and figures; prepare study schematic and model overview images summarizing data.
• Conduct literature reviews, write clear and concise synopses, maintain reference libraries.
• Prepare information and reports for in-house discussion, peer reviewed publications, and presentation at scientific meetings; contribute to manuscripts, slides, and other presentation materials based on study findings; contribute to grant applications.
• Perform administrative tasks related to journal and grant submissions, progress reports, IRB and IACUC applications, MTAs, etc.

Qualifications

Your qualifications should include:

• Bachelor’s Degree, ideally in biology, immunology, or other life science. Experience may substitute for minimum education requirements.
• 2 years of related program/project coordination experience.

Preferred qualifications:

• Advanced degree.
• Writing certificate preferred.
• Strong writing and communication skills.
• Manuscripts and grant submission experience strongly preferred.
• Biology, immunology, or other health-sciences background.
• Project management background.
• Experience with Endnote or Reference Manager.
• Ability to manage multiple projects and competing priorities with ease.

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Clinical Trials

Inside a CRO: The Essential Role of a Clinical Project Manager

Lindsey Pierce

What is a Project Manager’s role in a clinical trial?

Clinical trials are the backbone of drug development, ensuring that new treatments are both safe and effective. In this intricate process, the Clinical Project Manager stands as a linchpin, ensuring the seamless execution of these trials.

Pharmaceutical and biotech companies who hire a Clinical Project Manager from Precision for Medicine gain a dedicated professional who ensures timely delivery, budget adherence, and risk mitigation, all while maintaining the highest standards of clinical research.

What makes for an effective Clinical Project Manager?

A Clinical Project Manager, often abbreviated as PM, brings a unique blend of skills and expertise to the table:

• Strong attention to detail and organization:   Ensuring every aspect of the trial is meticulously planned and executed.
• Ability to track multiple deadlines and budgets:   Keeping the trial on track financially and temporally.
• Team leadership and collaboration abilities:   Unifying diverse teams towards a common goal.
• Excellent communication and interpersonal abilities:   Bridging the gap between sponsors, teams, and other stakeholders.
• Problem-solving and decision-making skills:   Navigating challenges that arise during the trial.
• Adaptability:   Meeting the diverse needs and personalities of team members.
• Comfort in challenging situations:   Handling difficult internal and client conversations with tact and professionalism.

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What are the responsibilities of a Clinical Project Manager?

A PM’s responsibilities span the entire lifecycle of a clinical trial, ensuring every phase is executed to perfection.

Pre-award responsibilities

• Supporting bidding and defense conversations to win the clinical trial.
• Informing on bid strategies, including sites, patient enrollment, and overarching strategies.
• Helping finalization of scope conversations, leading to clinical trial contract.

Responsibilities during study start-up

• Contributing to the review and finalization of the trial protocol and related documents.
• Creating the project plan and building the timeline.
• Assembling the study team into a cohesive unit.
• Assessing and recommending study vendors (if applicable for Sponsor at this stage).
• Projecting patient enrollment and evaluating study timeline impact.

Responsibilities during the trial

• Monitoring resourcing needs throughout the course of a trial.
• Managing the trial budget and ensuring vendor success.
• Recommending investigational sites and overseeing site activation timelines.
• Reviewing and tracking risks for study timeline delivery, implementing risk mitigation strategies.
• Ensuring quality data collection, protocol adherence, and patient safety.
• Maintaining proper documentation practices for audit readiness.
• Driving issue resolution and continuous process improvements.

Trial close-out responsibilities

• Managing study closeout and ensuring the archival of study-specific documents.
• Overseeing delivery of a clean and complete Trial Master File (TMF).
• Coordinating the Clinical Study Report.
• Evaluating final budget deliverables and ensuring all costs have been reconciled.

From study-start to finish: Journey of a Clinical Project Manager

Ensuring client satisfaction in communication and documentation

During the trial, the PM plays a pivotal role in maintaining a harmonious relationship between the CRO and the Sponsor. This is achieved by:

• Developing budgets and additional timelines that are realistic yet aggressive.
• Proactively identifying potential delays and out-of-scope work.
• Implementing proactive and reactive study challenge mitigations to keep the trial on track.
• Forecasting work to evaluate the remaining budget of the study.
• Motivating team members and investigators towards trial goals.
• Ensuring all study communication and documentation has been filed in the Trial Master File.
• Proactively identifying resourcing needs or gaps.
• Aligning trial conduct with sponsor strategic objectives.
• Maintaining constant communication with the sponsor to ensure client satisfaction and study team improvement.

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Clinical Project Managers are indispensable in balancing the health of a clinical study and ensuring its success. Their expertise, dedication, and meticulous approach ensure that drugs are brought to market efficiently, benefiting the industry as a whole and, most importantly, the patients awaiting new treatments.

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Clinical Research Project Coordinator- Neuroscience

Job posting for clinical research project coordinator- neuroscience at medpace, inc., job summary.

Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based  Project Coordinator  to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. Our therapeutic areas of focus include Microbiology, Oncology/Hematology, Cardiovascular/Metabolic/Renal, Infectious Disease/CNS/Ophthalmology and more. If you are looking for a fast paced, collaborative work environment in clinical research and want to develop your career even further, then this is the opportunity for you. Medpace provides Project Coordinators a 4-6 week training program that incorporates a virtual and hands on learning experience, especially for those without previous clinical research experience.

Responsibilities

• Engage in clinical trial management on a day to day level;
• Work closely with the project CTM for timely delivery of tasks consistently with a high degree of accuracy;
• Compile and maintain project-specific status reports;
• Interact with the Sponsor, study sites, and internal associates;
• Provide oversight and quality control of our internal regulatory filing system;
• Manage study supplies;
• Create and maintain project timelines; and
• Coordinate project meetings and produce quality meeting minutes.

Qualifications

• Minimum of a Bachelor’s Degree in Life Sciences field;
• Excellent computer, organizational, and time management skills; and
• Research experience preferred.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40 countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Cincinnati Campus Overview
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20 days
• Flexible work hours
• Discounted tuition for UC online programs
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Partnership and discount with onsite childcare
• Official Sponsor of FC Cincinnati
• Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets

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Clinical Research Project Coordinator- Oncology

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Qualitative Field Project Manager

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What They Do

What does a Research Project Coordinator do?

Research Project Coordinators take on a lead role in maintaining and creating processes that support the execution of a research project. Their duties include researching governance requirements, preparing for contract bidding, manage budgeting of a project to meet a specified timeline, and present findings of a project to all stakeholders involved. The Research Project Coordinator will also support administrative tasks, including producing corporate reports, organizing committee meetings, and developing a research database to track active milestones achieved.

• Responsibilities
• Skills And Traits
• Comparisions
• Types of Research Project Coordinator

Research project coordinator responsibilities

Research project coordinators play a crucial role in managing and overseeing research projects. They gather requirements, compile documentation, and oversee data management to ensure accuracy and standardization. As Alessandra Bryant PhD, LMFT, Assistant Professor of Marriage and Family Therapy at Fairfield University, advises, "Research proficiency is key. Get involved in undergrad if you can. As the field progresses, we need innovative thinkers to keep advancing our knowledge." This is evident in their tasks such as conducting primary research, analyzing data, and building statistical models. They also collaborate on reports and scientific posters, and participate in study recruitment and literature reviews.

Here are examples of responsibilities from real research project coordinator resumes:

• Manage study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder.
• Recommend administrative revisions to IRB submit studies including inform consent documents.
• Demonstrate small molecule are protective against DNA damage in mouse model of melanoma.
• Conduct analysis using SPSS which result in developing a new software for students to selecting college.
• Conduct primary research through interviews with Boston area travelers and analyze raw data into reports via SPSS.
• Maintain FDA correspondence and government documentation.
• Create print collateral and PowerPoint presentation templates.
• Conduct and analyze research in chemistry and pharmacology for anticancer treatments.
• Train physicians and FDA officials in critical appraisal of randomize clinical trial reports using internationally recognize methodology.
• Used common laboratory methods of synthesis, isolation, and purification in order to develop various hardener prototypes.
• Perform DNA experiments such as mini-preps, gel electrophoresis, bacteria plating, and prepare solutions in a molecular biology laboratory.
• Guide the technical implementation of an automate analysis system (electrophoresis station), with the enhancement of its operational efficiency.
• Coordinate and implement clinical research in accordance with the standards of good clinical practice and ICH guidelines.
• Develop advanced feature extraction methods using wavelet transform, Fourier transform and statistical time-series models for the recognition of acoustic sources.

Research project coordinator skills and personality traits

We calculated that 12 % of Research Project Coordinators are proficient in Data Collection , Patients , and Project Management . They’re also known for soft skills such as Interpersonal skills , Leadership skills , and Problem-solving skills .

We break down the percentage of Research Project Coordinators that have these skills listed on their resume here:

Oversee data management using Microsoft Access/Excel and created new policies that reduced errors in data collection while increasing standardization.

Conducted qualitative and quantitative evaluation and dissemination of clinical data collected to accompany biological specimens from cancer patients.

Project management of Phase I-IV drug and device trials, including regulatory compliance, budget monitoring, and participant recruitment.

Draft Emergency Action Protocol for the coordination of RxStat partners in the event of drug-related public health emergencies.

Maintain contact with research professors to ensure Behavioral Lab satisfaction and policy adherence, as well as IRB compliance

Perform statistical data analysis and interpret results within the context of business / customer objectives.

"data collection," "patients," and "project management" are among the most common skills that research project coordinators use at work. You can find even more research project coordinator responsibilities below, including:

Interpersonal skills. To carry out their duties, the most important skill for a research project coordinator to have is interpersonal skills. Their role and responsibilities require that "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals." Research project coordinators often use interpersonal skills in their day-to-day job, as shown by this real resume: "used interpersonal skills to welcome patients before clinical trial visit with nurse and doctor. "

Leadership skills. Many research project coordinator duties rely on leadership skills. "natural sciences managers must be able to organize, direct, and motivate others," so a research project coordinator will need this skill often in their role. This resume example is just one of many ways research project coordinator responsibilities rely on leadership skills: "conducted primary research and literature review and created best practices manual for youth leadership programs. "

Problem-solving skills. research project coordinators are also known for problem-solving skills, which are critical to their duties. You can see how this skill relates to research project coordinator responsibilities, because "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." A research project coordinator resume example shows how problem-solving skills is used in the workplace: "performed randomization and eligibility checklist generation, data entry, queries, warnings and delinquencies resolutions. "

Time-management skills. research project coordinator responsibilities often require "time-management skills." The duties that rely on this skill are shown by the fact that "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." This resume example shows what research project coordinators do with time-management skills on a typical day: "assist with industry related research projects working with internal team to meet multiple deadlines during the day. "

Communication skills. A commonly-found skill in research project coordinator job descriptions, "communication skills" is essential to what research project coordinators do. Research project coordinator responsibilities rely on this skill because "natural sciences managers must be able to communicate clearly with a variety of audiences, such as scientists, policymakers, and the public." You can also see how research project coordinator duties rely on communication skills in this resume example: "coordinate for dr. lloyd werk's obesity cluster grant funded by nih; communication, data collection & administrative tasks. "

Most common research project coordinator skills

The three companies that hire the most research project coordinators are:

• Medpace 15 research project coordinators jobs
• University of Maryland, Baltimore 12 research project coordinators jobs
• University of Washington 5 research project coordinators jobs

Choose from 10+ customizable research project coordinator resume templates

Compare different research project coordinators

Research project coordinator vs. clinical associate.

A clinical associate is responsible for supporting the operations of a medical facility by performing administrative and clerical duties as needed to provide high-quality care services for the patients and assisting health care professionals in performing medical procedures. Clinical associates monitor the conditions of the patients, administer medication, collect laboratory samples, and conduct initial medical assessments such as checking temperature and vital signs. A clinical associate must have excellent communication and organizational skills , especially on addressing different patients' needs and reporting the patients' progress to the physicians.

While similarities exist, there are also some differences between research project coordinators and clinical associate. For instance, research project coordinator responsibilities require skills such as "project management," "public health," "data analysis," and "research study." Whereas a clinical associate is skilled in "rehabilitation," "home health," "vital signs," and "cpr." This is part of what separates the two careers.

Research project coordinator vs. Coordinator and research assistant

Clinical research assistants are responsible for assisting with scientific studies and monitoring clinical trials. Other duties and responsibilities include ensuring compliance with clinical trial procedures and protocols, finding research subjects, and collecting and analyzing data. In addition, they are responsible for overseeing clinical site activities and preparing documentation, presentation, and correspondence on findings. They are also expected to prepare informed consent for clinical trials and conduct audits on research trials. The skills and qualifications required for this role include a bachelor's degree in psychology, science or related field, previous work experience, and excellent communication skills .

In addition to the difference in salary, there are some other key differences worth noting. For example, research project coordinator responsibilities are more likely to require skills like "project management," "research study," "r," and "status reports." Meanwhile, a coordinator and research assistant has duties that require skills in areas such as "research projects," "emr," "surgical procedures," and "epic." These differences highlight just how different the day-to-day in each role looks.

Research project coordinator vs. Clinical research assistant

A Senior Clinical Research Associate performs and coordinates all aspects of the clinical monitoring and site management process. They design, implement, and monitor clinical trials.

The required skills of the two careers differ considerably. For example, research project coordinators are more likely to have skills like "project management," "public health," "research study," and "powerpoint." But a clinical research assistant is more likely to have skills like "patient care," "research projects," "clinical research studies," and "excellent organizational."

Research project coordinator vs. Senior clinical research associate

Even though a few skill sets overlap between research project coordinators and senior clinical research associates, there are some differences that are important to note. For one, a research project coordinator might have more use for skills like "project management," "public health," "data analysis," and "research study." Meanwhile, some responsibilities of senior clinical research associates require skills like "oncology," "cra," "site management," and "field training. "

Types of research project coordinator

• Coordinator
• Project Coordinator
• Research Fellow
• Clinical Coordinator
• Clinical Research Coordinator
• Research Coordinator

Updated June 25, 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.

What Similar Roles Do

• What a Clinical Associate Does
• What a Clinical Coordinator Does
• What a Clinical Project Manager Does
• What a Clinical Research Assistant Does
• What a Clinical Research Associate Does
• What a Clinical Research Coordinator Does
• What a Clinical Research Manager Does
• What a Coordinator Does
• What a Coordinator And Research Assistant Does
• What a Project Coordinator Does
• What a Research Associate Does
• What a Research Consultant Does
• What a Research Coordinator Does
• What a Research Fellow Does
• What a Research Leader Does

Research Project Coordinator Related Careers

• Clinical Associate
• Clinical Project Manager
• Clinical Research Assistant
• Clinical Research Associate
• Clinical Research Manager
• Coordinator And Research Assistant
• Research Associate
• Research Consultant
• Research Leader

Research Project Coordinator Related Jobs

Resume for related jobs.

• Clinical Associate Resume
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• Clinical Research Assistant Resume
• Clinical Research Associate Resume
• Clinical Research Coordinator Resume
• Coordinator Resume
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• Research Associate Resume
• Research Consultant Resume
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• Research Fellow Resume
• Research Leader Resume
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• Zippia Careers
• Executive Management Industry
• Research Project Coordinator
• What Does A Research Project Coordinator Do

Browse executive management jobs

A description of Clinical Research Coordinator jobs and what they entail

Clinical research coordinators are usually supervised by clinical research managers. Their main task is to administer the clinical trials. Primary responsibilities normally include administering questionnaires, informing the participants about the objectives of the study, collecting data, and managing all the trials. They also have to adhere to all trial standards that have been set and also participate in recruitment of the subjects. Clinical research coordinators also have to engage with the subjects so that they can explain the things that are expected during the trial and also find out if they have any concerns. This means that a clinical research coordinator needs communicative and interpersonal skills.

For those interested in becoming clinical research coordinators, or enhancing their skills in this role, the Clinical Research Coordinator course provides comprehensive training and certification.

The responsibilities:

Maintaining records of all studies as per the guidelines.

Sticking to all ethical standards.

Sticking to all the regulatory standards set, including those covered in the ICH-GCP course .

Administering questionnaires.

Managing the budget dedicated to the research.

Overseeing the running of the trials as smoothly as possible.

Understanding and engaging with the subjects so as to know all issues.

Making sure that all equipment and supplies that are necessary for the success of the study are working and in stock.

Participating in the recruitment efforts of the participants, a topic extensively covered in the Clinical Trials Assistant Training .

Working with the laboratories so as to share findings.

Requirements:

The qualifications of a clinical research coordinator usually depend on your locations or employer. In most cases, for you to access clinical research coordinator jobs you should:

Have an associate nursing degree or any related field

Experience of two years within the healthcare industry

Analytical mindset

Be attentive to detail

Have interpersonal skills which are exceptional

Be ready to continue learning even without being prompted to do so, which can be further supported by the Advanced Clinical Research Project Manager Certification .

Great skills in organizing

Have great verbal and written communication skills

Additional certifications such as the Pharmacovigilance Certification , CRA , Advanced Principal Investigator Physician Certification , and Medical Monitor Certification are also beneficial for those looking to further their careers in clinical research.

7 Steps To Becoming A Clinical Research Coordinator

Understanding what clinical research organizations are and what they do.

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Clinical Research Project Coordinator

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Clinical Research Coordinator Lead

How to apply.

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

An exceptional opportunity is available for a highly motivated and experienced Clinical Research Coordinator Project Manager/Lead to oversee the clinical research activities within the Obstetrics and Gynecology Department with the PEACE Project Grant. A $7.8 million grant from the National Institutes of Health will fund a joint research effort entitled Partnering for Equity: An Academic and Community Alliance to Eliminate Disparities throughout the Fibroid Experience (PEACE) by researchers from multiple institutions.

We are looking for a candidate who can work independently, and in collaboration with multiple project PIs and community members with guidance required in only the most complex situations. The candidate should be able to set up and streamline study operations, maximize efficiency, and ensure the successful completion of clinical studies.

The successful candidate will be experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team. This position will work closely with principal investigators and other research team members to accurately and efficiently carry out a range of tasks and provide study coordination for multiple research studies of high complexity across research sites.   The role will also provide functional supervision for one or more junior clinical research team members. The candidate should be able to gather and understand internal or external issues and recommend solutions/best practices and solve complex problems and take a broad perspective to identify solutions. They may lead functional teams as well. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

At onWHARD we celebrate diversity and are committed to creating an inclusive environment for all team members. We know that our differences fuel innovation and excellence and understand that diversity and inclusion are critical to our success. We welcome applicants from all backgrounds, cultures, orientations, and experiences.

CRC STATEMENT:

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Lead position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

Expert level knowledge, skills, and abilities within all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Specific duties will include:

Project Management and Research Administration Responsibilities

• Will serve as the central administrative coordinator, facilitating communication across research teams, sponsors, and other stakeholders across the different sites.
• Will independently oversee common project activities, establish administrative protocols, budget assessments, implementation methods, and track and maintain IT resources.
• Independently draft reports, organize meetings with detailed agendas and minutes, and manage project logistics including Community Advisory Board (CAB), Steering Comm. (SC), internal and external advisory board (IAB/EAB) meetings, and organizing of events for dissemination of research findings.
• Proactive and meticulous oversight of forms, databases, regulatory files, and creating SOPs.
• Responsible for financial and staff management to meet project goals and will have the autonomy to make significant decisions in line with project objectives.
• Maintain minutes and Action plans from standing meetings
• Other activities as needed for the overall PEACE grant

Clinical Research Coordinator Responsibilities

• As an integral part of the PEACE study team, works closely with Principal Investigators, program manager, and various teams to shape and execute the study's overarching strategy.
• Organize and facilitate all aspects of standing recurrent meetings including MPI meetings, monthly Steering Committee Meetings, and Project PI meetings
• Plan and execute national annual PEACE meeting.
• Be the primary administrative contact for the program
• Responsibilities also include handling start-up, active, and closing phases of the project and overseeing inventory.

Research Regulatory Coordinator Responsibilities

• Handle, support, oversee the submission of IRB applications for all projects, create study SOPs, and ensure compliance with all study-related submissions and quality assurance.
• Monitor and address site compliance for subject safety, develop methods to improve participant protection, and create tools to enhance site adherence to regulations for the safe development of investigational products.
• Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.

Research Data Coordinator Responsibilities

• Create and manage databases, including designing logic, drafting Case Report Forms (CRFs), identifying data elements, and developing database in REDCap.
• Additionally, responsible for establishing processes, tools, and training to ensure data is captured accurately and consistently in line with ALCOA-C principles within the REDCap system.
• Candidate will work with other program staff, developing and presenting educational materials, to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations.

Training/Community Engagement/Other

• Facilitate effective communication between community and academic partners.
• Help initiate PEACE Pilot grant funding applications. Facilitate various aspects of the pilot grant process, including online application management, submission coordination, review and selection procedures, and compiling reports from pilot grantees.
• Work with Communications Specialist to maintain database of word and graphic based products including flyers, social media messages, etc.  
• Assist in supporting key personnel in project documentation and manuscript preparation; associated tasks with the Steering Committee's efforts and in align with NIH publication requirements.
• Provides mentorship of other clinical research staff; maintains certification.
• Employees in this classification typically analyze, compare and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities.
• Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.

Supervision Received:

This position reports directly to the Research Operations Senior Manager for Women's Health and Reproductive Disparities Collaborative. 

Supervision Exercised:

Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.

Required Qualifications*

• Bachelor's or Master's degree in Research Administration, Public Health, Social Work, Psychology, Business, Education, Social Sciences, or related field
• Certification is required through Association of Clinical Research Professionals ( ACRP ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association ( SOCRA ) as a Certified Clinical Research Professionals (CCRP) or equivalent.   Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc . within six months of date of hire.   (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Medical or public health research background
• Fluency in Microsoft Software i.e. Word, PowerPoint, Excel, etc.
• At least 10 years of experience as a program or research coordinator/manager
• Fluency in REDCap database building and management skills required.
• Demonstrable experience in managing multidisciplinary and multicultural teams.
• A commitment to diversity, equity, and inclusion, and cultural sensitivity.
• Demonstrated high degree of initiative and resourcefulness
• Able to work independently and work collaboratively with diverse groups across the research continuum (e.g., faculty, patients, community members, frontline providers, research managers, policymakers, research administration, and administrative staff)
• Experience coordinating multisite research projects, including budgets and workplans.
• Knowledge of and experience with IRB processes, submitting research studies to the University of Michigan's Institutional Review Board (IRBMed or IRB-HSBS).
• Exceptional attention to detail, and excellent written and oral communication skills
• Excellent organizational, leadership, and decision-making skills.
• Willingness to travel throughout Michigan and nationally to conferences, as needed
• Proficiency in -and research management software including reference management and file sharing software (e.g., Dropbox, Google Drive, Trello, Zotero), communication and meeting management (e.g., Zoom, Teams, Slack); and presentation software (e.g., Canva, etc.)

Level Specific Requirements:

• CRC Governance Committee review and approval 
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 5+ years of directly related experience in clinical research and clinical trials is necessary

Desired Qualifications*

• Masters or PhD
• Experience using social media platforms
• Survey research experience and skills; Mixed-methods skills including qualitative and quantitative research methods
• Qualtrics experience
• Experience in mixed-methods or qualitative research
• Experience with data visualization and synthesis
• Ability to manage responsibilities and manage time effectively to meet deadlines.
• Demonstrate excellent problem-solving, analytical, and critical thinking skills
• Ability to set priorities, handle multiple assignments and deadlines and display excellent judgment while operating in a flexible and professional manner; strong ability to multitask while remaining focused is essential.
• Demonstrated ability to work independently with minimal supervision. and adapt to the needs of the program
• Demonstrated ability to work with diverse teams of people in a diplomatic, inclusive, collaborative and effective manner; Ability to effectively lead diverse work teams
• Working knowledge of applicable University policies and procedures preferred
• Ability to make independent decisions while working toward a shared strategic vision

Work Locations

This position is hybrid, with 2-3 days/week onsite work in Ann Arbor, MI *required* and/or community-based work throughout Michigan.   There will be some travel to national meetings.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. 

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

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Clinical Research Coordinator I

• Madison, Wisconsin
• SCHOOL OF MEDICINE AND PUBLIC HEALTH/CARBONE COMP CANCER CENTER
• Partially Remote
• Staff-Full Time
• Opening at: Jun 3 2024 at 10:20 CDT
• Closing at: Aug 6 2024 at 23:55 CDT

Job Summary:

The Clinical Research Coordinator will join the Clinical Research Central Office (CRCO) at the University of Wisconsin Carbone Cancer Center (UWCCC) to work on cancer clinical research within one or more Disease-Oriented Teams under the direction of a Clinical Team Manager. The UWCCC participates in Phase I, II and III oncology clinical research funded by national, federal and private sponsors. This position will interface with hospital personnel, inpatient and outpatient clinics and a referral network as necessary to identify, collect, and disseminate patient and protocol information. The selected candidate must demonstrate strong oral and written communication skills and an ability to work with patients and health care providers. The incumbent will work independently and as part of a group on multiple projects simultaneously, prioritizing projects based on deadlines and interdisciplinary collaboration. Attention to detail, time management and excellent organization will be critical to the success of this position.

Responsibilities:

• 5% Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s)
• 30% Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional. May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
• 30% Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
• 5% Identifies work unit resources needs and manages supply and equipment inventory levels
• 30% Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred Bachelor's Degree Preferred focus in biological or health sciences, health care, or related field

Qualifications:

At least 1 year of clinical research experience strongly preferred but not required.

Full Time: 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $50,000 ANNUAL (12 months) Depending on Qualifications

Additional Information:

- Work experience should demonstrate dependability, flexibility, and maturity. Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability. Employees will also be expected to uphold UWCCC core values as defined below: - Respect: Demonstrate respect for self and others -- behave professionally. - Integrity: Act with integrity and honesty. - Teamwork: Commit to and demonstrate teamwork. - Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance. -TB testing and a Caregiver Background Check will be required at the time of employment. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial Caregiver Check to be eligible for employment under the Wisconsin Caregiver Law and then every four years. Please note that successful applicants are responsible for ensuring their eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without need of employer sponsorship) on or before the effective date of appointment.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a resume and cover letter as a part of the application process. Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position. You will also be asked to provide three professional/supervisor references during the application process. References will not be contacted prior to notifying you.

Jennifer Wilkie [email protected] 608-262-8025 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Coord I(RE015)

Department(s):

A53-MEDICAL SCHOOL/CARBONE CANC CTR/CANC CTR

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

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Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.

The Department of Anesthesiology, Pain and Perioperative Medicine at Stanford University is seeking a Clinical Research Coordinator Associate. The Clinical Research Coordinator will perform duties related to helping establish and coordinating moderately complex aspects of one or more clinical studies . The Clinical Research Coordinator will join a vibrant and innovative team committed to pediatric pain research under P.I., Dr. Jennifer Rabbitts. This lab includes multiple NIH funded research projects that collectively aim to address the impact of the pain and opioid epidemics on children, through identifying factors that contribute to development of chronic pain, and testing treatments to prevent chronic pain in children and adolescents. The Clinical Research Coordinator will w ork under close direction of the principal investigator and research supervisor/manager.

At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.

For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.   Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.   Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.   Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.   Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Interact with lab members and collaborators to assist with other studies and tasks as needed.
• Other duties may also be assigned

DESIRED QUALIFICATIONS:

Fluency in Spanish. 

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:  

Occasional evening and weekend hours.

WORK STANDARDS

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,  http://adminguide.stanford.edu .

The expected pay range for this position is $31.73 to $36.54 per hour. 

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

This position is located at Stanford Research Park (Porter and Page Mill Road). Option for hybrid work may be offered.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 103738
• Work Arrangement : Hybrid Eligible

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Assistant Clinical Research Coordinator - Hybrid - 131241

Job description, #131241 assistant clinical research coordinator - hybrid.

UCSD Layoff from Career Appointment : Apply by 07/26/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants : Apply by 08/07/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

Under supervision from Principal Investigator and Clinical Research Supervisor II in the Pulmonary, Critical Care & Sleep Medicine Division, the Research Coordinator supports the ICU clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary disorders including COPD, cystic fibrosis and IPF. Responsible for independently coordinating and managing research studies, to include protocol management, screening for patient eligibility, consenting subjects, data collection and entry, patient follow-up, query resolution, and database management. The Research Coordinator will assist in the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Will independently process Institutional Review Board (IRB) submissions and amendments.

Reporting directly to Clinical Research Supervisor II, responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.

MINIMUM QUALIFICATIONS

Theoretical knowledge in biology, immunology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

Experience performing clinical research duties in a clinical research environment.

Demonstrated experience interpreting medical charts, experience in abstracting data from medical records.

Experience with clinical trials participant or study subject recruitment.

Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

Demonstrated knowledge of FDA policies regulating clinical trials.

Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

Experience coordinating study startup activities.

Experience with interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

Experience maintaining files and keeping records.

Demonstrated knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.

Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

Excellent interpersonal skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.

Ability to work independently. Ability to maintain confidentiality.

Experience completing clinical trials case report forms via hard copy and online.

Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

Demonstrated experience using database, word processing and spreadsheet applications.

Demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.

Demonstrated experience working with patients with Pulmonary Hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.

Must have access to reliable transportation.

Experience with investigational drug authorization criteria.

PREFERRED QUALIFICATIONS

Certification as a clinical research associate or coordinator.

Experience working with research bulk accounts.

SPECIAL CONDITIONS

Occasional evenings and weekends may be required.

Must be willing to travel to occasional meetings and work weekends and evenings as needed.

Must be willing to work with human blood and biohazardous materials.

Employment is subject to a criminal background check and pre-employment physical.

Pay Transparency Act

Annual Full Pay Range: $66,753 - $107,407 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $31.97 - $51.44

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. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

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.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

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Posted : 7/24/2024

Job Reference # : 131241

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