About this role
Provide study coordinator/data management/regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing excellent customer support and guidance in the clinical trials arena.
Responsibilities:
- Assure all study requirements are met and documented and meet both internal and external regulations in accordance with protocol guidelines.
- Maintain logs, including tracker submissions and update the CTO Oncore database in a timely manner according to CTO SOPs.
- Design systems for coordinating, compiling and submission of data; design workflow processes and participate in quality assurance measures; coordinate site visits.
- Manage all patient and/or protocol data as assigned and respond to queries in a timely fashion.
- Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required.
· Bachelor’s degree required or equivalent combination of education and experience.
· Medical and/or science experience/education preferred.
· Clinical research certification preferred.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Other facts
About McLaren Health Care
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 28,000 full-, part-time and contracted employees and more than 113,000 network providers throughout Michigan, Indiana and Ohio.
As part of its Graduate Medical Education (GME) program, McLaren maintains academic affiliations with medical schools at Wayne State University, Michigan State University and Central Medical University. McLaren’s seven (7) GME campuses offer 27 residencies and eight (8) fellowship programs that train over 650 future physicians annually. All GME programs at McLaren are overseen and managed centrally by the Department of Academic Affairs.
What you'll do
- The Clinical Research Coordinator II will provide support to the Clinical Trials Office by managing study requirements and ensuring compliance with regulations. Responsibilities include maintaining logs, coordinating data submissions, and managing patient data.
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