Regulatory Affairs Specialist - Cv Research

Receives direction/guidance from the Mayo Clinic Cancer Center (MCCC) leadership, including the Clinical Research Office Medical Director, the Protocol Review and Monitoring System Chair, the Cancer Center Statistics Director, and the Clinical Research Office Operations Manager. Reports to the Protocol Development Coordinator Supervisor. Functionally directs support staff, i.e., administrative assistants, clerks, etc. Provides consultative direction to investigators within the MCCC research programs. Works cooperatively with support staff, investigators, accountants, administrators, nurses, pharmacists, protocol development and data management personnel, legal staff, statisticians, laboratory personnel and representatives from pharmaceutical industry, federal government agencies (e.g., FDA, NCI, OHRP, etc), equivalent agencies outside of the U.S., and other cancer research organizations, including cancer cooperative groups, cancer centers, and non-Mayo healthcare facilities.

Assists in the planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents (drugs, biologics, 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 MCCC research programs. Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs. Advises and provides support to MCCC investigators in relation to the preparation, submission, and maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications and other equivalent functions as may be applicable to the research programs of the MCCC. Performs other regulatory affairs/compliance-related functions, and participates in departmental committees and work teams as directed or assigned.

A bachelor's degree (BA, BS) preferably in the health sciences or management, and a minimum 3-5 years relevant experience in a complex healthcare environment are required. 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 preferred. Exceptional human relations and communication (written, verbal, and listening) skills 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 other and to 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 have the ability to lead, motivate and influence others. Compliance issues may create difficult situations for the individuals involved; 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 comprehension 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.

Preferred Qualifications: Must have demonstrated the capacity to comprehend complex structures and connections. The ability to exercise good judgment in ambiguous situations while under pressure and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.