Compliance Coordinator – Cooperative Studies

Mayo Clinic•Rochester, MN

3d•$75,920 - $113,922•Hybrid

About The Position

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 and the NCCCTG Executive Committee concerning institutional status/performance based on participation, accrual, compliance and audit results. 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.

Requirements

Must live within 100 miles of a Mayo Clinic campus/site.
Requires travel approximately 30% of the time.
Excellent communication skills.

Responsibilities

Planning, development, and implementation of compliance activities.
Proactive review of research records and internal investigations of research activities.
Management of all phases of the Cancer Center's internal and external audit programs (pharmacy, IRB, chart review).
Coordination and participation in on-site audits for the Cancer Center, NCCTG, ECOG, CPN, and CTSU.
Providing consultative expertise on regulatory and policy questions.
Interpreting and applying regulatory and policy requirements from Federal agencies and the IRB.
Assisting with the verification of adherence to regulatory protection of human subjects and handling of investigational agents (INDs).
Interacting with NCI staff regarding institutional performance issues.
Making recommendations/reports to the CCCSOC and the NCCCTG Executive Committee.
Developing and writing elements of audit reports.
Educating and training other personnel, both internally and externally.