Clinical Research Activation Coordinator

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

The Clinical Research Activation Coordinator I is responsible for providing customer-focused management of start-up activities for MCC trials. This includes but not limited to the overall management and oversight of the following processes:

• Disease Working Group management, coordinate trials through the feasibility/activation process as the project manager.
• Complete and submit Sponsor site questionnaires and feasibility checklist.
• Request and submit Confidentiality Disclosure Agreements to OSP.
• Schedule Site qualifying visits with the Sponsor and Study team to review our site facility and procedures.
• Enter new studies into Oncore.
• Collect and submit protocol documentation for Radiation safety and Biosafety review.
• Submit to the PRMC for scientific review in a timely manner.
• Coordinate with the PI and study team to schedule and conduct study start up meetings and site initiation visits with Sponsors.

The Clinical Research Activation Coordinator I also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear client and internal team communication and documentation. This position works directly with other departments in the CTO in setting priorities and expectations for study start-up.

Minimum Hiring Standards

• 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.
• BA/BS degree with an emphasis in the basic sciences, healthcare or database design and
  management.
• Prior experience working with clinical research sponsors.
• Experience in an academic medical center.
• Experience using healthcare based clinical information systems.
• Knowledge in FDA, ICH regulations governing clinical research.
  
  

Preferred Hiring Standards

• Experience with Clinical Trial Coverage Analysis decisions preferred.
• Knowledge and/or experience with NCI CCSG expectations is preferred.
• Previous experience coordinating and managing clinical trials.
• Project Management knowledge.