Minnesota

Clinical Research Regulatory Specialist

Job description          

Introduction
Allina Health is dedicated to the prevention and treatment of illness and enhancing the greater health of individuals, families and communities throughout Minnesota and western Wisconsin. A not-for-profit health care system, Allina Health cares for patients from beginning to end-of-life through its 90+ clinics, 12 hospitals, 16 pharmacies, specialty care centers and specialty medical services that provide home care, senior transitions, hospice care, home oxygen and medical equipment, and emergency medical transportation services. Allina Health is a vibrant, growing organization with opportunities to suit your professional skills and a diverse work environment to match your specific interests. We believe employees are our greatest asset and are dedicated to helping you develop and maximize your professional skills. The Commons, located in Minneapolis, is the headquarters of Allina Health, a not-for-profit health care organization serving patients and communities. Approximately 1,600 corporate and administrative service employees work at offices within Midtown Exchange, the site of the historic Sears retail complex at Chicago Avenue and E. Lake Street. This community landmark, adjacent to the campus of Abbott Northwestern Hospital, part of Allina Health, is the second largest building in Minnesota and includes offices, an internationally themed public market and residential units.
Responsibilities
This position will ensure compliance to federal, state and local rules and regulations as they relate to the proper conduct of clinical research and human subject protection. The person in this position will manage application process for new study submissions to the IRB, and provide guidance and mentoring to staff regarding federal, state and local regulations on the proper conduct of human subjects’ research. This person will lead communication between department and regulatory entities throughout the study, manage all regulatory documents for each study throughout the life of the study, develop an auditing process to ensure studies are inspection (federal and or sponsor) ready at all times. Will lead research compliance program and develop and maintain standard operating procedures which are in line with federal, state and local regulatory entities including but not limited to the FDA, HIPAA, OHRP and the Institutional Review Board. This individual may also assist with managing registry or non-treatment studies e.g.: consenting, tracking, data collection/submission and follow-up if needed Additionally, he/she will assist investigators with protocol writing, consent forms, and other regulatory documents to comply with IRB and HIPAA requirements for research studies.


Education
Bachelor’s Degree required in biological sciences. Master’s degree preferred.
Qualification/Skills
Minimum of 1-3 years of experience in IRB regulatory work. Must possess excellent written and verbal skills, as well as strong problem solving and decision making skills. Must have knowledge of, and experience in, the interpretation of Federal and State regulations particularly regarding the protection of human subjects in biomedical research (to include working knowledge of Federal regulations for human research: 21 CFR parts 50, 56, 312, and 812. Ability to interpret and apply laws and regulations to ensure overall protection of human participants. Ability to advice and counsel on matters of general research compliance and ethical human participant research practices. High level of experience and comfort working independently with senior leadership, faculty, staff, students, medical professionals and external agencies in complex organizations. Proficient with relevant computer programs. Experience in operating electronic IRB applications.
Work Schedule
40 hours per week Monday -Friday Hours are somewhat flexible

Location/Community Information
Minneapolis boasts being both cosmopolitan yet small enough that you can find a place to call home whether on a lake, golf course, or in an adjoining suburb. With the fast pace of activity there are professional sports, theater, or enough parks for a quiet walk. The area has numerous schools and colleges, both public or private, and enough teams for all weekend athletes to join. Located in Minneapolis Population = 380,000 Service Area = 2,882,245 Community Resource Links: Community Information School Digger Explore Minnesota MN Dept of Education Minneapolis St. Paul MagazineSt. Paul Pioneer Press Twin Cities Living MagazineStar Tribune
Closing
If you are interested in becoming part of our award winning team of professionals, please apply online today. Allina Health is committed to providing Equal Employment Opportunities to all employees and applicants. EO M/F/Disability/Vet Employer.
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Introduction
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Introduction
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