Assistant Director, Clinical Research, Quality Assurance and Compliance

The Massey Comprehensive Cancer Center has an exciting opportunity for an Assistant Director, Clinical Research, Quality Assurance and Compliance to join our team! Our employees and applicants come from diverse backgrounds. We hire great people from a wide variety of backgrounds, not just because it’s the right thing to do, but because it makes VCU stronger.

“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 Comprehensive Cancer Center is a nationally ranked cancer center located in the heart of Downtown Richmond. All full-time staff is 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. Flexible work arrangements are available for this position.

Veterans: VCU faculty and University and Academic Professionals are now eligible for enhanced leave accrual rates based on verified military service. The calculation of these leave accrual rates will include a veteran's verified service in the military, National Guard, Reserves (active or inactive duty) and full-time state or Federal National Guard duty. Eligible employees must supply DD-214 documentation for each period of military service to receive this benefit.

Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/

Position Primary Purpose and General Responsibilities Massey Comprehensive Cancer Center is seeking a Senior Manager/ Assistant Director Quality Assurance and Compliance will report into the Senior Director Clinical Operations and Management of the Massey Comprehensive Cancer Center (MCCC), Clinical Trials Office (CTO) with a dotted line report into the Associate Director for Clinical Research and may have up to two additional auditors in the Quality Assurance and Compliance Unit. This position provides coordination for the administration, support, auditing, and oversight of operational research compliance functions for the MCCC. These functions include protection of human subjects; export controls; research involving radiation, biorepositories, biohazards, and controlled substances. This position participates in all aspects of research integrity, compliance, and privacy initiatives, including workforce orientation, incident response & documentation, research compliance and investigations, educating stakeholders on research compliance topics, and supports policy and procedure development. The incumbent also works with institutional officials in Conflict of Interest disclosure/reporting process.

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.

Minimum Hiring Standards
• Bachelor’s degree in business administration, accounting, management, healthcare administration, science, nursing, or other related degrees. Combination of relevant education and experience may be considered in lieu of degree.
• Experience 2-5 Years’ experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse Coordinator and proven experience as an Lead Auditor
• 5 years of experience related to legal, regulatory compliance auditing, clinical research, or health information management services.
• Thorough knowledge of GxP and appropriate knowledge and of research regulations and guidelines
• Excellent oral and written communication skills
• Strong problem solving and critical thinking, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/workload
• Prior Management Experience
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.

Preferred Hiring Standards
• Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS.
• Experience with Cerner, EPIC, RedCAP and OnCore is preferred. Knowledge and familiarity of e-regulatory systems (Veeva), DocuSign, ImageNow and other applications used in the conduct of clinical research along with the relevant regulations
• 5 Years’ experience in clinical trials auditing
• 2 Years’ experience in oncology

Preferred Licenses/ Certifications
• CCRC - Cert Clin Research Coordinator (Preferred) or
• CCRA - Cert Clin Research Associate (Preferred) or
• CCRP - Cert Clin Research Prof (Preferred)