Regulatory Affairs Coordinator – Cancer Center Compliance (Remote)

Mayo Clinic•Rochester, MN

20d•Remote

About The Position

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.

Requirements

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 facilitating change.
Must be very detail oriented.
Must have the ability to work independently and productively with a minimum of direction and to routinely exercise initiative and sound judgment.
Must possess effective leadership and management qualities, including the ability to motivate and to influence others.
Compliance issues may create difficult situations for the involved individuals. Therefore, fairness in approach is essential.
Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for individuals.
Computer literacy and medical terminology are essential.
Must be efficient in the use of personal computers for word processing, spreadsheets, data analysis, creation of graphs and charts, presentations, electronic communications, and research.
Must have demonstrated the capacity to comprehend complex structures and connections.
The ability to exercise good judgment in ambiguous situations while under pressure; strong coping skills are required.
Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Must be a U.S. citizen, permanent resident, refugee or asylee.

Nice To Haves

A strong understanding of FDA regulations and proficiency in medical terminology is preferred.
The following certifications are preferred: Cert Clinical Res Professional (CCRP), Cert Clinical Research Assoc (CCRA), Certified Clinical Research Co (CCRC) and Regulatory Affairs Certificate (RAC) and Certified IRB Professional (CIP).

Responsibilities

Planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents
Monitoring the internal and external regulatory environment
Researching relevant regulatory issues
Evaluating the adequacy and effectiveness of compliance processes and controls
Proposing compliance-enhancing recommendations to MCCC leadership
Facilitating the development and implementation of new or revised MCCC policies and procedures
Participating in compliance-related administrative activities
Serving as a resource concerning policies, procedures, and regulations
Representing the MCCC research programs from a regulatory perspective
Managing the submission and ongoing maintenance of FDA IND applications and Health Canada CTAs
Supporting the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office