HomeVirginiaRegulatory Affairs Specialist
Virginia Commonwealth University

University of Richmond, VA

Regulatory Affairs Specialist

LocationUniversity of Richmond, Virginia, 23173
Employment TypeContractor
Date Posted2022-10-06
Direct Apply
Valid Through2023-01-14

Job Description:

Massey Cancer Center

“To improve the lives of all Virginians by delivering cutting-edge cancer care through patient-centered prevention and treatment; high-impact, innovative research; community input and engagement; and education and training of the next generation of researchers and healthcare professionals.”

Virginia Commonwealth University (VCU) Massey Cancer Center is a nationally ranked cancer center located in the heart of Downtown Richmond. All full-time staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and academic-professional-benefits/

Position Primary Purpose and General Responsibilities
  • Deliver exceptional Institutional Review Board (IRB) and related regulatory support to the Principle Investigator (PI)
    and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant
    safety and welfare.
  • Provide IRB and related regulatory support to the PI and members of the research study team throughout the life of
    the study (activation to closeout).
  • Ensure safety of research participants and endeavor to minimize risk to the institution, center and PI by maintaining
    audit-ready regulatory files at all times and uploading currently approved protocols, informed consents and PRMC
    approvals in OnCore upon receipt.
  • Monitor study activities to ensure all requisite regulatory approvals are on file prior to the research team consenting
    / enrolling research participants at Massey or an affiliate site.
  • Proficient utilization of electronic research systems/databases to ensure timely submissions and compliance with
    multiple IRBs and related regulatory entities.
Minimum Hiring Standards
  • Bachelor’s degree with oncology experience in an academic medical center preferred or equivalent experience, education
    and training.
  • Independent judgment and critical-thinking skills required.
  • Ability to demonstrate successful implementation of time management skills.
  • Ability to multi-task and prioritize autonomously.
  • Demonstrated leadership experience.
  • Exceptional attention to detail and data accuracy.
  • Ability to work in a fast paced, demanding environment and adapt to changing client status, regulations and work
  • Detail-oriented, exceptional organizational skills
  • Proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel,
    spreadsheet management, PDF file creation/use, online database use/maintenance, internet-based research,
    network & online file maintenance & management, and custom report generation.
  • Demonstrated knowledge of medical terminology.
  • Ability to provide own transportation to attend meetings within the service area or at training locations.
  • Massey Cancer Center supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment.
Preferred Hiring Standards
  • Experience with oncology standard care practice and/or research protocols.
  • Experience with NCI-sponsored cooperative group, private industry and investigator-initiated trials.
  • Experience with Oncore or other clinical trial management system (CTMS).
Salary Range: Commensurate with Experience

Position Details:

Department: Massey Cancer Center
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Non-Exempt

Contact Information:

Contact Name: Emily Foster

Contact Email: *****/b>

Contact Phone: *****

Job ID: 8706797841277387392

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