Mayo Clinic Regulatory Affairs Specialist - CVRU in Rochester, Minnesota
Why Mayo Clinic The needs of patients drive research at Mayo Clinic. As doctors treat patients and see opportunities for advancing patient care, they work together with Mayo scientists and research teams to develop new and improved diagnostic tools, medications, devices, treatment protocols and more. Encouraging and including contributions from diverse individuals is critical to Mayo Clinic's future. By leveraging the strengths that each diverse individual and group brings to the table, Mayo Clinic gains the strategic advantages of accelerated innovation, better problem solving, enhanced productivity and job satisfaction, improved quality, and, most importantly, provides better ways to meet the needs of our patients.
Position description 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.
Qualifications 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.
Additional 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.
License or certification Exemption status Exempt
Compensation Detail Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum salary every 2 weeks is approx $1949.60, based on a full-time position.
Benefits eligible Yes
Schedule Full Time
Hours / Pay period 80
Schedule details Weekend schedule Site description Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.
Category Clinical Labs and Research
Career profile Research
Job posting number 140850BR
Recruiter Jill Squier
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.
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