The Compliance Department at MSK is seeking a Institutional Compliance Manager, Conflict of Interest and Research to join their team. This manager will handle daily management of the Conflict of Interest program at MSK. In addition, the manager will be involved in areas with significant research compliance components, including procedures for investigating research misconduct, financial issues in research management and activities related to animal research subjects and research-related issues.
The Institutional Compliance Manager will:
- Manage the institutional conflict of interest program, including the computer system designed for reporting and managing of outside activities. Maintain expert knowledge in use of system; provide guidance to staff who use the system.
- Maintain the MSK policy on Conflict of Interest and Conflict of Commitment; update the policy to reflect changes; at least every two years, prepare the policy for formal review by the COIAC and the Joint Audit Committee of the Board. Develop and maintain expertise in the COI policies required by NIH, FDA and other regulatory agencies.
- Actively collaborate with colleagues in MSK Office of General Counsel, Research and Technology Development, Office of Clinical Research and clinical departments to ensure the timely and accurate review of disclosures made through the centralized reporting application.
- Produce standard and ad hoc reports on disclosures, management plans and other variables to monitor conflict of interest issues. Maintain thorough and detailed records of all disclosures and their adjudication. Provide written response to all staff who seek pre-approval for outside activities to convey whether the activity is approved, approved with a management plan or not approved.
- Develop and maintain staff training on COI topics; assure that the content is reviewed and updated at least annually and as needed. Monitor data on training completion to assure that all persons covered by the COI policy complete training. Make use of institutional resources (the intranet; electronic posters; MSK Life and other institutional publications) to communicate with staff about Conflict of Interest policies.
- Manage the research compliance program, in coordination with the Vice President of Compliance, interfacing with administrative and research staff throughout the institution to act as a resource on research policies and regulations and to proactively identify and address issues that may impact on research compliance.
- Conduct audits and participate in investigations in areas of assigned responsibility and expertise.
The Institutional Compliance Manager needs:
- A Bachelor’s Degree AND 7-10 years of compliance or regulatory area, research or hospital operations experience; OR
- A Master’s Degree with 4-7 years of the above experience.
- Candidates who possess a Juris Doctorate may be eligible for an Assistant General Counsel title.