Regulatory Affairs Team Lead - Massey Cancer Center
Virginia Commonwealth University
Richmond, VA
Full-time
Management
Posted on June 17, 2023
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/
The Regulatory Affairs Team Lead works directly with the Regulatory Affairs to lead a designated sub-set
of the regulatory team charged with the delivery of exceptional Institutional Review Board (IRB) and
related regulatory support to the Principal Investigator (PI) and research team ensuring: adherence to
the protocol, regulatory compliance, and protection of participant safety and welfare.
JOB DESCRIPTION
• Provide day-to-day reference, guidance, and training to designated regulatory team members.
• Assist and provide insight on regulatory applications, submissions, and continuing review,
routine and expedited reports to regulatory authorities for designated regulatory team
members.
• Provide general guidance, daily oversight, mentorship and direct training for a designated subset
of the regulatory affairs team.
• Provide regulatory affairs training and information updates for new hire training as well as
ongoing regulatory staff development.
• Assist Regulatory Manager with optimization of OnCore system to support regulatory oversight
and generate applicable data, metrics and related reports to effectively monitor and manage
regulatory affairs activity for protocols conducted at MCC locally, network affiliates and other
institutions / sites participating in MCC investigator-initiated protocols
• Serve as regulatory special projects and initiatives working group lead as appointed / requested.
• 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.
QUALIFICATIONS
Education
BA/BS degree or degree equivalency with 6 years of experience.
Certification/License
ACRP/SOCRA (or equivalent) certification preferred.
Experience
3 years minimum experience in clinical research, 5 years preferred, with at least two year experience in
an academic medical center, or equivalent combination of experience (might include regulatory affairs
management, clinical research project management, CRO, pharmaceutical industry or sponsor-investigator
trial experience).
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.
Experience with oncology standard care practice and/or research protocols, NCI-sponsored cooperative group, private industry and investigator-initiated trials and OnCoreTM or other clinical trial management system (CTMS), preferred
Salary Range: Commensurate with experience, starting at $54,000
Position Details:
Department: Massey Cancer Center
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Exempt
VCU Job slotting: Sr. Research Administrator I