Regulatory Affairs Coordinator – Cancer Center Compliance; Remote

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.

• Medical:
  Multiple plan options.
• Dental:
  Delta Dental or reimbursement account for flexible coverage.
• Vision:
  Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement:
  Competitive retirement package to secure your future.

Responsible for planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents (drugs, biologics, device, etc.). Monitors the internal and external regulatory environment to promote centralized, coordinated, and proactive identification, development, and implementation of new or revised policies, procedures, etc. applicable to MCCC research programs. Researches relevant regulatory issues and evaluates the adequacy and effectiveness of compliance processes and controls related to Mayo Clinic Cancer Center (MCCC) research programs.

Proposes compliance‑enhancing recommendations to MCCC leadership and facilitates the development and implementation of new or revised MCCC policies and procedures pertaining to human research protections and the investigational use of agents. Through these activities, facilitates the compliance of MCCC research programs with Mayo Foundation and National Cancer Institute (NCI) policies, and U.S. and foreign government regulations, including those of the U.S. Food and Drug Administration, Health Canada, and other equivalent agencies.

Participates in other compliance‑related administrative activities including development and delivery of educational programs, and assistance, as necessary, during select external audits and site visits (i.e., FDA, and NCI or other sponsors). Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs. Represents the MCCC research programs from a regulatory perspective in national forums/venues. Presentations at meetings or other conferences, seminars, and classes, and occasional travel may be required.

Manages the submission and ongoing maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Health Canada Clinical Trials Applications (CTAs), and other equivalent activities as may be applicable to the research programs of the MCCC. Supports the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office, and promotes efficiency and adaptability through the coordinated development and maintenance of policies, working instructions, standard operating procedures, protocol templates, etc.,

related to the protection of human subjects and investigational use of agents (drugs, biologics, etc.). May have direct supervisory responsibilities.

A bachelor's degree (BA,BS) and a minimum of 5 years’ experience in compliance, quality management, audit, or other relevant healthcare experience is required. Typical duration of prior experience is 5-10 years. Knowledge and experience in the interpretation and application of laws and regulations relating to human subjects’ research protections and investigational use of agents (drugs, biologics, etc.) are required. Exceptional human relations skills and excellent communication skills (written, verbal, and listening) are required.

Organizational project management skills are essential. Should have an inquiring, analytical and persistent disposition to enable the asking of follow‑up questions that might not occur to others and look deeply into each area of concern. Collaborates with management in identifying improvement opportunities and developing corresponding solutions. Must be flexible and capable of adapting to and…