Regulatory Affairs Specialist

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/

Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.

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
  environment.
• 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).