About Us
McLaren Health Care, headquartered in Grand Blanc, Michigan, is a $7.3 billion, fully integrated health care delivery system committed to quality, evidence-based patient care and cost efficiency. The McLaren system includes 12 hospitals in Michigan, ambulatory surgery centers, imaging centers, a 640-member employed primary and specialty care physician network, commercial and Medicaid HMOs covering more than 732,838 lives in Michigan and Indiana, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, a National Cancer Institute-designated comprehensive cancer centers. McLaren has 20,000 full-, part-time and contracted employees and more than 113,000 network providers throughout Michigan, Indiana and Ohio.
Research Compliance Quality Improvement Education Specialist
Responsible for providing on-going support and education to the research community at McLaren and its subsidiary hospitals to ensure compliance with applicable institutional, FDA, OHRP, HIPAA, and GCP requirements and guidelines. In addition, this position provides administrative support in cases of alleged Research Misconduct and other research compliance matters. Position often requires extended hours and flexibility in work schedules immediately prior to and during audits, inspection, accreditation visits, and for special projects.
Essential Functions and Responsibilities:
- Facilitate the execution of system wide training programs, workshops and conferences for investigators, IRB members and research staff:
- Develops and presents monthly education sessions.
- Coordinates and presents workshops on issues in the area of regulatory compliance and/or best practices.
- Conducts annual conferences on human research protections.
- Supports the research community through the development of a responsible conduct of research education program and by providing tools to aid in the appropriate conduct of research.
- Responsible for developing and implementing a comprehensive clinical research compliance auditing plan.
- Plans and conducts compliance review activities associated with clinical research studies that include but are not limited to the review of all research-related activities and documents to assess and evaluate the compliance of those activities to internal policies, standards operating procedures (SOP's), and relevant regulatory requirements.
- Plans and conducts quality improvement reviews to verify that clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOP's, Good Clinical Practices, and relevant regulatory requirement.
- Bachelor’s degree in a scientific discipline or a related field or equivalent combination of education and experience.
- 5 years of direct experience with HRPP, IRB, and/or research compliance.
- Certification in Healthcare Research Compliance (CHRC) or able to obtain within 2 years of hire
- Degree in nursing
- Experience with AAHRPP Accreditation process.
Equal Opportunity Employer
McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.
