Sr. Manager/ Assistant Director Quality Assurance and Compliance
University Code 32912 University Title Administrator 2, Research University Job Family Research & Innovation ORP Eligible Yes For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Job Series Scope of Search Regional Working Title Sr. Manager/ Assistant Director Quality Assurance and Compliance Position Number 592480 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Massey Cancer Center Organizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
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.
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 .
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)
Anticipated Hiring Range commensurate with experience Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours M-F Job Open Date 04/29/2021 Posting will close on or before Open Until Filled Yes Job Category Research Is this a restricted position? No Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link https://www.vcujobs.com/postings/105658 Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Please describe any clinical trial regulatory compliance
(Open Ended Question)
- * What is your experience regarding Good Clinical Practices, as
well as FDA rules & regulations in relation to clinical
(Open Ended Question)
Required Documents Optional Documents
- Cover Letter/Letter of Application
- Other Document