Regulatory Affairs Coordinator - Cancer Center Compliance (Remote)

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Mayo Clinic. Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer site. Any information collected there is subject to their terms and privacy notice. 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. Benefits Highlights • 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. Responsibilities 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. Qualifications 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. 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). Note: Visa sponsorship is not available for this position. Must be a U.S. citizen, permanent resident, refugee or asylee. Exemption Status Exempt Compensation Detail $74,422.40 - $111,696.00 / year; Education, experience and tenure may be considered along with internal equity when job offers are extended. Benefits Eligible Yes Schedule Full Time Hours/Pay Period 80 hrs Schedule Details Monday through Friday 8 am - 5 pm Weekend Schedule N/A International Assignment No Site Description Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. ( Equal Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" ( . Mayo Clinic participates in E-Verify ( and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. Recruiter Stephanie Baird Equal opportunity As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available. If you have questions about this posting, please contact [email protected] Apply tot his job