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    Regulatory Clinical Research Coordinator - Charlottesville, United States - University of Virginia

    University of Virginia
    University of Virginia Charlottesville, United States

    3 weeks ago

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    Description

    The Cancer Center's Office of Clinical Research (CC OCR) is looking for individuals to join their team as a Regulatory Coordinator.

    The Regulatory Coordinator will be responsible for independently submitting and processing UVA Cancer Center protocols for regulatory review by Protocol Review Committee (PRC), IRB-HSR, Central IRBs and FDA.

    This position works on the team of the OCR Regulatory Manager to ensure the efficient and compliant regulatory management of clinical research protocols throughout the Cancer Center.

    The incumbent serves as the contact with relevant regulatory authorities (PRC, IRB, OHRP, FDA, etc.) and sponsor representatives. The incumbent is responsible for assigned projects, with optimal efficiency, through effective performance.


    Duties include:

    • Draft Protocol Review Committee (PRC) submissions.
    • Write abbreviated protocols and consents for Institutional Review Board (IRB) submission.
    • Prepare Central Institutional Review Board (CIRB) expedited submissions to the IRB.
    • Process adverse events, amendments/revisions, personnel changes, study continuations, Investigational New Drug (IND) safety reports, and investigator brochures.
    • Maintain regulatory compliance using informatics platform OnCore.
    • Administer physical and electronic trial files.
    • Draft, collect and maintain essential regulatory documents.
    • Work with clinical trial sponsors to maintain protocol compliance.
    • Submit Informed Consent Form (ICF) language to appropriate committees (e.g. HIRE).
    • Respond to Data and Safety Monitoring Committee (DSMC) reports.
    • Prepare and transmit responses generated from internal Post Approval Monitoring (PAM) audits.
    • Adhere to deadlines, edit material as requested by governing boards, and follow progress of approval steps for trial protocols.
    • Work on the preparation, completion, and organization of regulatory documentation for each clinical trial as needed and primary assignment allows.
    • Notify Principal Investigator and/or supervisor of study regulatory status changes.
    • Convey accurate and comprehensive study information to Principal Investigator, supervisory personnel, study sponsor, members of the interdisciplinary team involved in the studies, and peers.
    • Serve as the liaison with the sponsor for all assigned studies.
    • Prepare study status reports as required.
    • Keep current in federal, state and local regulations governing clinical trial activities and performs all activities in compliance with these regulations.
    • Attend team meetings.
    Minimum Requirements

    Compliance Coordinator Trainee


    Education:
    High School Diploma


    Experience:
    None. Some experience in a health care setting preferred.


    Compliance Coordinator:

    Education:
    High School Diploma


    Experience:
    At least 2 years of relevant experience.

    Physical Demands

    This is primarily a sedentary job involving extensive use of desktop computers.

    Hiring Ranges


    Compliance Coordinator Trainee:
    $45,000-$50,000


    Compliance Coordinator:
    $51,000-$56,000


    Application Instructions:
    Apply Now.

    Internal applicants must apply through their UVA Workday profile, search Find Jobs and then R Complete an application online and include the following documents:


    • A CV/resume
    • A cover letter
    All documents can be loaded into the resume submission field, multiple documents can be submitted into this one field. Incomplete applications will not be considered.


    Please note that this is a restricted position and continuation is dependent upon the availability of the position, funding, and satisfactory performance.

    This position cannot offer sponsorship.

    For questions about the application process, please contact Margaret Weeks, Academic Recruiter. Before a formal offer of employment is extended, the selected candidate will undergo a background check per university policy.


    The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff.

    We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers.

    All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.

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