At Great Lakes Clinical Trials, our regulatory team coordinates and guides the review and approval process of all research activities associated with clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare.
Applicants must have Bachelor’s degree or higher, preferably with a medical background. Clinical Research Regulatory experience is preferred. Regulatory Coordinators interact with project coordinators from Sponsors, CRO’s, IRB’s and our own clinical research staff.
This position includes completion of Regulatory Documents including FDA 1572, Financial Disclosure Forms, IRB submissions and Site Status Reports. The ideal candidate will be self-directed, accurate and organized. Must be a problem solver, multitasker and able to respond to IRB Regulatory requests requests in a timely manner.
Regulatory Coordinators need excellent communication and organizational skills, and must have proficient computer skills.