Compliance Coordinator – Cooperative Studies

Note: This is a hybrid position. The employee is required to live within 100 miles of a Mayo Clinic campus/site.

The Compliance Coordinator is responsible for the planning, development and implementation of compliance activities including the performance of proactive review of research records and internal investigations of research activities. Manages all phases of the Cancer Center's internal and external audit programs, including pharmacy, IRB, and chart review, with minimal direction. Coordinates and participates in a large number of on-site audits for the Cancer Center, NCCTG, Eastern Cooperative Oncology Group (ECOG), CPN ( Chemo Prevention Network and CTSU each year at locations throughout North America. Provides consultative expertise regarding regulatory and policy questions. Interprets and applies regulatory and policy requirements promulgated by Federal agencies and the IRB. Assists with the verification of adherence to regulatory protection of human subjects and the handling of investigational agents (INDs). Interacts with NCI staff regarding institutional performance issues. Makes recommendations/reports to the CCCSOC. Uses excellent communication skills to develop and write various elements of the audit reports and educate/train other personnel, both internally and externally. This position requires travel approximately 30% of the time.

A Bachelor's degree is required; Masters Degree preferred. Five to seven years experience in compliance, quality management, audit, and/or relevant healthcare experience.
Knowledge of IRB policies and federal regulations related to research involving human subjects.
Strong leadership qualities and organizational project management are essential. Must have the ability to work interdependently with compliance activities. Strong oral and written communication skills are necessary.
The incumbent should have strong analytical and inferential capabilities; will collaborate with management in identifying opportunities and developing corresponding solutions; must be flexible and capable of adapting to and facilitating change; must be very detailed oriented which includes: strong project management skills with the ability to function independently and productively. Where difficult situations arise, fairness in approach is essential. Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for involved individuals.

This position is not eligible for visa sponsorship. Must be U.S. citizen, permanent resident, refugee or asylee.