About Us
McLaren Health Care is a fully integrated health network committed to quality, evidence-based patient care with locations in Michigan and Indiana. The McLaren system includes 13 hospitals in Michigan, ambulatory surgery centers, imaging centers, a primary and specialty care physician network, commercial and Medicaid HMOs, 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, one of only 53 National Cancer Institute-designated comprehensive cancer centers in the U.S.
Manager Clinical Trials Office Regulatory
Responsibilities:
- Coordinates the orientation program for new Regulatory Clinical Research Coordinators. Updates orientation documentation as indicated with changes in internal/external regulations in the conduct of clinical research.
- Provides administrative support to Protocol Review Committee and use of ePRMS within OnCore®.
- Provides oversight in the coordination of regulatory assignments. Directly supervises regulatory supervisors. Approves/rejects projects as indicated.
- Analyze research data and prepare statistical reports related to clinical trials regulatory staff performance.
- Implements and maintains a Quality Assurance Program for regulatory data management which includes adherence to Standard Operating Procedures, Food and Drug Administration guidelines, ICH, and Good Clinical Practice. Ensures compliance to both internal and external regulatory guidelines.
- Bachelor’s degree required, Master’s degree preferred.. Demonstrated leadership skills required. Regulatory experience required.
- Prior management experience monitoring day-to in hiring, training, discipline in over-sight of patient and regulatory data Research Assistants preferred.
- Knowledgeable in internal/external regulations, Good Clinical Practice in the conduct of clinical trials, research budgets, federal grant requirements, etc.
- SoCRA certification or equivalent required.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
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.
