Research Compliance Quality Auditor
Health Care/Research Center
Tampa, Florida
We are assisting a non-profit, health care provider and research center in their search for a Research Compliance Quality Auditor to be based in the Tampa, Florida Area.
Why Join Us:
- Named one of the top 10 health care centers in the United States
- Excellent benefits, including medical, dental & vision, retirement plans, PTO and more
- Education assistance available for those seeking to further their skills and education in eligible programs
- On-Site clinic for employees, free of charge
Responsibilities:
- Prepare schedules and conduct research related audits.
- Create necessary reports and follow-up to ensure all studies are conducted and billed in compliance with all applicable regulatory and billing requirements, Good Clinical Practice (GCP) guidelines and organizational quality standards.
- Coordinate and lead corrective and preventative action (CAPA) plans, audit correspondence and memos.
- Create tracking logs including information of CAPA commitments/completion.
- Identify and assess areas of research compliance risk for the Company and recommend and ensure appropriate corrective actions.
- Provide written reports of research compliance activities and trends to management
- Participate in industry training, workshops and discussion groups to maintain required knowledge of applicable regulations and government, industry and company GCP standards
- Create/develop content for research compliance training.
- Provide one-on-one and group training to research staff as necessary to ensure compliance.
- Support other QA projects as needed
Qualifications:
- Education: Bachelor’s degree preferred
- LPN license/certification or 1 year specific GCP auditing experience.
- Experience in research quality and/or auditing environment with expertise, knowledge, and CP experience in auditing clinical trials.
Application Process:
- Please send resume to Steve Harrison at steve@conselium.com
