clinical research associate 2 salary

How much does a Clinical Research Associate make in the United States?

• Clinical Research Associate Salary The average Clinical Research Associate salary in the United States is $121,115 as of July 29, 2024. The range for our most popular Clinical Research Associate positions (listed below) typically falls between $58,705 and $183,526. Keep in mind that salary ranges can vary widely depending on many important factors, including position, education, certifications, additional skills, and the number of years you have spent in your profession. With more online, real-time compensation data than any other website, Salary.com helps you determine your exact pay target.

• Clinical Research Associate I Participates in the design, administration and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. May require ACRP or SOCRA Clinical Research Professional exam completion. Requires a bachelor's degree in Science or its equivalent. Typically reports to a supervisor or manager. Work is closely managed. Works on projects/matters of limited complexity in a support role. Typically requires 0-2 years of related experience. View Clinical Research Associate I Salary Alternate Job Titles :Clinical Trials Data Analyst I, Clinical Trials Research Associate I, Clinical Research Associate I Categories : Pharmaceuticals , Biotechnology , Entry Level , Science and Research
• Clinical Research Associate II Participates in the design, administration and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. May require ACRP or SOCRA Clinical Research Professional exam completion. Requires a master's degree in science or equivalent. Typically reports to a supervisor or manager. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2-4 years of related experience. View Clinical Research Associate II Salary Alternate Job Titles :Clinical Trials Data Analyst II, Clinical Trials Research Associate II, Clinical Research Associate II Categories : Pharmaceuticals , Biotechnology , Science and Research
• Clinical Research Manager Manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. May require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. Manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. View Clinical Research Manager Salary Alternate Job Titles :Clinical Research Programs Manager, Clinical Research Manager Categories : Pharmaceuticals , Biotechnology
• Research and Development Associate I Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a bachelor's degree. Typically reports to a supervisor or manager. Works on projects/matters of limited complexity in a support role. Work is closely managed. Typically requires 0-2 years of related experience. View Research and Development Associate I Salary Alternate Job Titles :R & D Support Associate I, Scientific Research Associate I, Research and Development Associate I Categories : Pharmaceuticals , Biotechnology , Energy and Utilities , Science and Research
• Research and Development Associate II Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a bachelor's degree. Typically reports to a supervisor or manager. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work. Typically requires 2 to 4 years of related experience. View Research and Development Associate II Salary Alternate Job Titles :R & D Support Associate II, Scientific Research Associate II, Research and Development Associate II Categories : Pharmaceuticals , Biotechnology , Energy and Utilities , Science and Research
• Research and Development Associate III Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. May require a master's degree. Typically reports to a supervisor or manager. Work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. Typically requires 4-7 years of related experience. View Research and Development Associate III Salary Alternate Job Titles :R & D Support Associate III, Scientific Research Associate III, Research and Development Associate III Categories : Pharmaceuticals , Biotechnology , Energy and Utilities , Science and Research
• Research and Development Associate IV Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. May require a master's degree. Typically reports to a manager or head of a unit/department. Work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. Typically requires 7+ years of related experience. View Research and Development Associate IV Salary Alternate Job Titles :R & D Support Associate IV, Scientific Research Associate IV, Research and Development Associate IV Categories : Pharmaceuticals , Biotechnology , Energy and Utilities , Science and Research
• Research and Development Associate V Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. May require a master's degree. Typically reports to a manager or head of a unit/department. Works autonomously. Goals are generally communicated in "solution" or project goal terms. May provide a leadership role for the work group through knowledge in the area of specialization. Works on advanced, complex technical projects or business issues requiring state of the art technical or industry knowledge. Typically requires 10+ years of related experience. View Research and Development Associate V Salary Alternate Job Titles :R & D Support Associate V, Scientific Research Associate V, Research and Development Associate V Categories : Pharmaceuticals , Biotechnology , Energy and Utilities , Science and Research
• Scientist - Clinical Research Assumes lead role in various clinical research projects. Proposes, plans, organizes and executes experiments and research. Secures grants and funding for research and is responsible for controlling budgets. Summarizes findings in reports and communicates results. Interacts with other scientists within and outside of the organization. Provides recommendations that influence extensive clinical research activities. Requires an advanced degree. Typically reports to head of a unit/department. Work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. Typically requires 4 -7 years of related experience. View Scientist - Clinical Research Salary Alternate Job Titles :Clinical Research Lead Scientist, Senior Clinical Researcher, Scientist - Clinical Research Categories : Science and Research , Biotechnology
• Clinical Research Director Directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Typically reports to top management. Manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. Typically requires 5+ years of managerial experience. View Clinical Research Director Salary Alternate Job Titles :Clinical Research Programs Director, Clinical Research Director Categories : Healthcare - Administrative , Science and Research

Average Clinical Research Associate II Salary

The average salary for a Clinical Research Associate II is $78,145 in 2024

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How do clinical research associate iis rate their jobs, common health benefits for a clinical research associate ii, gender breakdown for clinical research associate iis.

FAQs About Clinical Research Associate IIS

What is the highest pay for clinical research associate iis.

Our data indicates that the highest pay for a Clinical Research Associate II is $91k / year

What is the lowest pay for Clinical Research Associate IIS?

Our data indicates that the lowest pay for a Clinical Research Associate II is $65k / year

How can Clinical Research Associate IIS increase their salary?

Increasing your pay as a Clinical Research Associate II is possible in different ways. Change of employer: Consider a career move to a new employer that is willing to pay higher for your skills. Level of Education: Gaining advanced degrees may allow this role to increase their income potential and qualify for promotions. Managing Experience: If you are a Clinical Research Associate II that oversees more junior Clinical Research Associate IIS, this experience can increase the likelihood to earn more.

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Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Recruiter Reported CRA II Salary Ranges

I spoke with recruiters from ICON and Labcorp. They gave me salary ranges for CRA II positions in case anyone is curious.

ICON: 110-120k Labcorp: 105-109k

No mention of sign-on bonus.

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Clinical Research Coordinator Associate (Fixed-term 2 years)

🔍 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.

Do you think rapid-acting treatments for psychiatric disorders are the future of applied neuroscience? We are looking for a highly motivated and personable Clinical Research Coordinator Associate (CRCA) Fixed-term 2 years to join the research group of Dr. Boris Heifets MD PhD in the Department of Anesthesiology at Stanford University School of Medicine. Dr. Heifets’ research group conducts both basic neuroscience and clinical research aimed at understanding how an emerging group of therapies, like ketamine and psilocybin, might function in the brain and how they could be used to outcomes for patients undergoing surgery and in chronic pain. This is an excellent opportunity to become a key player of a team thriving to make impactful contributions to the practice of perioperative medicine and pain management.  

Join a dynamic, highly collaborative research group as a clinical research coordinator. This job involves coordinating clinical care, patient recruitment, follow-up, and managing communications with IRBs, the FDA and the DEA. Our group is currently running two clinical trials, and collaborating with several other research groups on other trials. Direction and academic mentorship will be provided by the principal investigator, and opportunities for academic contributions are certainly available. 

You will be responsible for day-to-day operations of two or more clinical studies, working with a highly collaborative team that includes Principal and co-investigators, fellow, residents, research nurse, medical students, and colleagues in the Psychiatry department at Stanford and UCSF, and Stanford’s Pain Medicine Division.

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.
• Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Knowledge of principals of clinical research and federal regulations.
• Ability to work effectively in a fast-paced environment with multiple projects and timelines.
• Familiarity with IRB guidelines and regulations.
• Previous experience with SPSS and other related database applications.
• Previous experience working with Biobehaviorial studies and use of psychiatric scales.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• Fluency in Spanish is a plus. 

  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.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Fixed-Term
• Requisition ID: 104094
• Work Arrangement : On Site

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CLINICAL RESEARCH ASSOCIATE, LEAD, DCRI

Durham, NC, US, 27710

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

MegaTrials CRA Lead (Job Code 2985)

Position Summary

Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the Mega Trial team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.

** NOTE: This position may have an opportunity to work remotely.  All Duke University and Duke Health remote workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio and New Hampshire

Core Job Responsibilities

• Provide leadership for the Mega Trial project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:
• Define, assign, coordinate, oversee and assess utilization and productivity of team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines.

Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.

• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.
• Identify resource needs and supervise team members’ work assignments, utilization and productivity.
• Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leader of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes and related documents.
• Review and approve team deliverables focusing on quality and timeliness of all activities within the defined scope of work.
• Oversight, and management of the Mega Trials SONAR report for each trial including ARO SONAR report when applicable.
• Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.
• Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.
• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.
• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.
• Apply best practices to site management clinical trials processes.
• Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).
• Collaborate with internal and external partners to develop trial-specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
• Facilitate communication between designated internal and external contacts (including contracts, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.
• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.
• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners
• Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training, Provide and document regular feedback to individual team members. Maintain documentation, providing specific examples of performance issues.
• Recognize accomplishments of individual team members and the team as a whole.
• Manage all aspects of performance management including compiling and providing feedback to the team members’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans.
• information exchange
• Attend appropriate Mega Trial leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.
• Assist in the development, implementation and revision of processes, SOPs and standard forms.
• Oversee team dynamics to foster professional relationships.
• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.
• Encourage and support cross-functional and therapeutic information exchange.
• Participate in special assignments as requested by project leader.
• Interview job candidates and make hire recommendations for teams.
• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.
• Encourage team to seek opportunities for personal development.
• Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.
• Perform other related duties incidental to the work described herein

Education/Training

Bachelor’s degree preferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experience in clinical trials research.  Prefer 3 years directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF         RELEVANT                  EDUCATION         AND/OR EXPERIENCE

Required Knowledge, Skills and Abilities

A sterisk (*) or other notation to distinguish KSAs that are required at the time from those that are expected to be demonstrated at the conclusion of orientation, training, or probationary period for the position.

• * Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
• * Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
• * Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
• Ability to collaborate with team members to achieve trial-specific goals within specified timelines
• Ability to collaborate with internal and external partners to achieve departmental and organizational goals
• Ability to lead others and foster teamwork; ability to manage, motivate and lead teams
• * Proficient computer skills including MS Office, Word, Excel and PowerPoint; able to learn and use computer applications
• Ability to train and coach site management and clinical monitoring team members
• Ability to direct and manage competing individual and team activities to meet trial objectives, timelines and budget
• * Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
• * Strong knowledge of medical terminology
• Understanding of scientific application to clinical trials research
• * Technical knowledge and skills for monitoring procedures and practices
• Knowledge of clinical research trial operations
• * Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
• Understanding of departmental SOPs and systems
• *Ability to travel 25%, some for consecutive nights

Registration, Certification or Licensure

• Valid U.S. driver’s license
• ACRP CCRC or CCRA, or SoCRA CCRP is a plus

Working Conditions

• Extensive use of telephone and electronic mail systems
• Extensive repetitive keyboarding motions
• Extensive focusing on computer monitor for long periods of time
• Occasional lifting and moving of heavy business documents
• Occasional travel with a laptop computer and heavy business documents

Bachelor’s degree pre ferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experie nce in clinical trials research.  Prefer 3 yea rs directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF    RELEVANT          EDUCATION                AND/OR EXPER IENCE

·     * Strong technical spelling and grammar skills, including revi ewing and proof reading of business documents and communications

·     * Ability to write,< span>speak, and present s trategies clearly and concisely in a variety of commu nication settings and styles

·     * Strong interpersonal skills, abili ty to establish and promote positive business relationships , customer service oriented

·     Ability to collaborate with team memb ers to achieve trial-specific goals within specified timeli nes

Minimum Qualifications

Work requires graduation from an accredited degree program providing 1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or 2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five years closely related research experience. **State of North Carolina license may be required.**

None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.

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Site Monitor I/II - FSP (Any region)

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Problem-solver
• Self-starter

About This Role

Parexel FSP is looking for multiple Site Monitors I and Site Monitors II to join the US team in any region.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

Build relationships with investigators and site staff.

Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. -Conduct remote Qualification Visits (QVs).

Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval, -Site activation, -Patient recruitment & retention.

Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

Work in a self-driven capacity, with limited need for oversight.

Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

Address/evaluate/resolve issues pending from the previous visit, if any.

Follow-up on and respond to appropriate site related questions.

Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

Conduct remote visits/contacts as requested/needed.

Generate visit/contact report.

Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

Assess & manage test article/study supply including supply, accountability and destruction/return status.

Review & follow-up site payment status.

Follow-up on CRF data entry, query status, and SAEs.

Conduct on-site study-specific training (if applicable).

Perform site facilities assessments

Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

Ensure timely and accurate completion of project goals and update of applicable trial management systems.

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

Ensure that assigned sites are audit and inspection ready

Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

Show commitment and perform consistent high quality work.

Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.

Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

Provide input and feedback for Performance Development Conversation(s).

Develop expertise to become a subject matter expert.

Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Problem solving skills

Able to work independently, seeking/taking guidance when necessary.

Sound presentation skills.

Client focused approach to work.

Ability to interact professionally within a client organization with the support of manager

Flexible attitude with respect to work assignments and new learning.

Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).

Willingness to work in a matrix environment and to value the importance of teamwork.

Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

Sound interpersonal, verbal, and written communication skills.

Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.

Developing ability for effective time management in order to meet study needs, team objectives, and department goals.

Developing ability to work across cultures.

Shows commitment to and performs consistently high quality work.

Ability to successfully work in a (‘virtual’) team environment.

Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

Attention to detail.

Holds a driver’s license where required

Knowledge and Experience:

Previous relevant work experience preferred.

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

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TEAM IMPRESSIONS

Why Clinical Research Associates work at Parexel

Patient-focused in everything we do

We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

Supportive and inclusive environment

We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

Career growth and development

We develop your skills through training, mentorship, and career advancement programs.

Flexible work arrangements

We focus on outputs and results, not where and when you work.

Diverse therapeutic areas and project exposure

We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams.

Advanced Technology

We recognize the importance of first-time quality to bring treatments to patients faster.

Learn About Our Culture

Neuroscience Careers

Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

Careers in Inflammation & Immunology

Each day, we’re working toward building a deeper connection and understanding with those who count on us – the patients.

Cell and Gene Careers

Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

Our work culture

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Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

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In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

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Begin your career journey at Parexel with our emerging talent programs or our internships, placements and apprenticeships. Advance science by keeping the patients at the heart.

About our hiring process

It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.

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Location: Mexico

Learn about Parexel Mexico, where you can be part of a rapidly growing team dedicated to improving patient health. Enjoy flexible work options, a supportive and collaborative culture, and continuous professional growth. Discover how you can make a global impact with us.

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Clinical Research Associate II

United States

Clinical Research Associate II participates in the design, administration and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Being a Clinical Research Associate II ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. Additionally, Clinical Research Associate II may require ACRP or SOCRA Clinical Research Professional exam completion. Requires a master's degree in science or equivalent. Typically reports to a supervisor or manager. The Clinical Research Associate II occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Clinical Research Associate II typically requires 2-4 years of related experience.

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