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Sr. Manager/ Assistant Director, Clinical Research, Quality Assurance and Compliance

Richmond

Sr. Manager/ Assistant Director, Clinical Research, Quality Assurance and Compliance

  • req577
  • Richmond, Virginia, United States, 23284
  • Massey Cancer Center
  • Virginia Commonwealth University
Position Primary Purpose and General Responsibilities
Massey 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 Cancer Center (MCC), 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 MCC. 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
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
  • Prior Management Experience

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

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

 

Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer

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