Clinical Research Regulatory Specialist I, Clinical Trials Unit (Hybrid)

• Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.
• Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
• Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
• Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
• Embraces the principles and practice of leadership and professionalism in clinical research.

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.