3-5 years of experience
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Employment Type:
Full time
Job Category:
Health Care Provider
Regulatory Affairs Specialist Job
Mayo Clinic | Rochester, Minnesota
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Job Description

Department: Cancer Center

A Life-Changing Career

Responsibilities: 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.

Benefit Eligible: Yes
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 $1,836.80, based on a full-time position.
Hours/Pay Period: 80
Schedule Details: Daytime Hours

Recruiter: Natalie Brewster

Why Mayo Clinic? Mayo Clinic provides the highest quality patient care by placing the needs of the patient first. We are the largest integrated, not-for-profit medical group practice in the world with approximately 60,000 employees working in a unique environment that brings together the best in patient care, groundbreaking research and innovative medical education. We offer a highly competitive compensation package, which includes exceptional benefits, and have been recognized by FORTUNE magazine as one of the top 100 "Best Companies to Work For".

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.

Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).

Job Posting Category: Research
Job Posting Number: 86020BR

About Mayo Clinic

Company Description

Mayo Clinic is the first and largest integrated, not-for-profit medical group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy of "the needs of the patient come first." More than 3,800 physicians and scientists and 50,900 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Mayo Clinic also serves over 70 communities through Mayo Clinic Health System with locations in MN, IA, GA, and WI. Collectively, these locations care for more than 1 million people each year.

Company History

Perhaps it was fate, perhaps happenstance or maybe even luck. Whatever you decide, this is certainly a story about being at the right place at the right time -- a moment in history when scientific discovery made possible the creation of modern medicine. It's also a story of an extraordinary family -- Dr. William Worrall Mayo, a frontier doctor, and his two sons, Dr. William J. Mayo and Dr. Charles H. Mayo, and the great institution they built, Mayo Clinic. It's the story of a deadly tornado and the partnership that evolved between the Mayo family and the Sisters of Saint Francis. It's a story about unusual dedication, willingness to face a hostile and harsh environment, a story of discovery, sharing, collaboration, selflessness and generosity. It's also a story of how people came together in a small town on the edge of America's Great Plains and built the first integrated medical practice and how that practice developed a model dedicated to providing the best care to every patient every day.

Mission & Values

Mayo Clinic has a legacy of inspiring hope and contributing to health and wellbeing by providing the best care to every patient through integrated clinical practice, education, and research.

Working Here

What if a career could change your life?  Whether you are a nursing student, starting your professional life, or already have a substantial career in Nursing, you may sometimes wonder if you are doing the work you were meant to do.  As a Mayo Clinic Nurse you will become a vital member of a dynamic health care team, where you’ll experience the exceptional environment of one of the world’s cutting edge health care institutions.

Perhaps you imagine being part of a team where your colleagues inspire you to stretch and grow beyond your boundaries. Maybe you are looking for a purpose in life that gives you an opportunity to be part of a lasting legacy. Mayo Clinic provides the highest quality patient care by placing the needs of the patient first.  You’ll discover a culture of teamwork, professionalism and mutual respect – and most importantly, a life-changing career.

Hiring Information

Mayo Clinic has a multidisciplinary, team-oriented work environment that presents opportunities that may rarely be experienced elsewhere.  Each year more than a million patients from all 50 states and nearly 150 countries come to Mayo Clinic for care.  Mayo Clinic teams cared for 1,113,000 individual patients in 2011 at campuses in Minnesota, Florida, Arizona and Mayo Clinic Health Systems, a network of clinics, hospitals, and health care facilities serving communities in Minnesota, Iowa, Wisconsin, and Georgia.  A variety of specialty opportunities exist within hospital inpatient, Perioperative and perianesthesia, and ambulatory care areas depending on location of interest.


Mayo offers a wide variety of benefits for employees. They include paid time off, tuition assistance, relocation assistance and excellent health care coverage.

Honors & Awards

In 2012, FORTUNE named Mayo Clinic to its 15th annual 100 Best Companies to Work For list. This is Mayo Clinic's ninth consecutive year on the list. The Department of Nursing at Mayo Clinic in Rochester has been a Magnet status recipient since 1997.

Mayo Clinic is an affirmative action and equal opportunity educator and employer.