Clinical Research Regulatory Specialist II, Seidman Cancer Center (Hybrid)

What You Will Do Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%) Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (20%) Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials. (30%) Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%) Embraces the principles and practice of leadership and professionalism in clinical research. Provides mentorship and training on the clinical trial and regulatory process to staff members. (10%) Additional Responsibilities Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace. #J-18808-Ljbffr