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Mayo Clinic Coordinator - Regulatory Affairs - Cancer Center in Rochester, Minnesota

Why Mayo Clinic

Mayo Clinic is the nation's best hospital (U.S. News & World Report, 2022-2023) and ranked #1 in more specialties than any other care provider. We have a vast array of opportunities ranging from Nursing, Clinical, to Finance, IT, Administrative, Research and Support Services to name a few. Across all locations, you’ll find career opportunities that support diversity, equity and inclusion. At Mayo Clinic, we invest in you with opportunities for growth and development and our benefits and compensation package are highly competitive. We invite you to be a part of our team where you’ll discover a culture of teamwork, professionalism, mutual respect, and most importantly, a life-changing career!

Mayo Clinic offers a variety of employee benefits. For additional information please visit Mayo Clinic Benefits (https://jobs.mayoclinic.org/benefits/) . Eligibility may vary.

Position description

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)

  • 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.

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; strong coping skills are required.

  • Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Exemption status

Exempt

Compensation Detail

$68,785 - $103,209 / year

Benefits eligible

Yes

Schedule

Full Time

Hours / Pay period

80

Schedule details

  • This position serves the Mayo Clinic Comprehensive Cancer Center, Enterprise Regulatory Unit, servicing all campuses.

  • Monday - Friday

  • 8 hour shifts during core business hours, between 7-6pm with awareness that this role works across the Enterprise serving Arizona, Minnesota, and Florida time zones.

Weekend schedule

  • Weekends are uncommon and travel may be occasionally required.

Remote

Yes

International Assignment

No

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.

Recruiter

Kaela Peterson

EOE

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.

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.

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.

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