What are the responsibilities and job description for the RESEARCH COMPLIANCE PROGRAM MANAGER position at Moffitt Cancer Center?
Summary
Position Highlights:
The Research Compliance Program Manager evaluates issues of research non-compliance and manages all areas of an investigation, including oversight, follow up, and resolution. Under the direction of the Research Compliance Officer, the Research Compliance Program Manager will serve as a liaison between Research Operations and Research Compliance utilizing tact and diplomacy to communicate, build rapport, and foster strategic alliances to ensure the appropriate and independent investigation into research non-compliance. This position will also oversee and manage the GCP auditing function and provide education to the research community on research-related topics, ensuring compliance to all regulatory requirements. This position will also provide general support to the Research Compliance Program as needed.
Responsibilities
Position Highlights:
The Research Compliance Program Manager evaluates issues of research non-compliance and manages all areas of an investigation, including oversight, follow up, and resolution. Under the direction of the Research Compliance Officer, the Research Compliance Program Manager will serve as a liaison between Research Operations and Research Compliance utilizing tact and diplomacy to communicate, build rapport, and foster strategic alliances to ensure the appropriate and independent investigation into research non-compliance. This position will also oversee and manage the GCP auditing function and provide education to the research community on research-related topics, ensuring compliance to all regulatory requirements. This position will also provide general support to the Research Compliance Program as needed.
Responsibilities
- Evaluates issues of non-compliance and leads/oversees the investigation to include follow up and resolution.
- Assists with the development of an annual work plan based on a risk assessment.
- Develops and maintains research non-compliance policies, information, tools and resources on the website and other forums.
- Provides support to the Research Compliance Program as needed.
- Manages assigned staff
- Stays abreast of current industry trends and new regulations and compliance efforts related to research non-compliance, regulatory and Good Clinical Practice in order to analyze their impact on the organization.
- Bachelor’s Degree - field of study: Health Sciences, Healthcare Administration, Research Administration or background in a medical profession
- Minimum of five (5) years working experience in a research compliance and/or regulatory environment.
- Expertise, knowledge, and experience with investigating/auditing research non-compliance or research regulatory issues.
- Thorough knowledge of regulations as they pertain to research compliance, regulatory and Good Clinical Practice.
- Preferred Certification; not required: RHIT, RHIA, CCS, CCSP, CCA, CIC, COC, CPC, ACRP, CCRC, or CCRP.