Clinical Research Regulatory Specialist I, Clinical Trials Unit (Hybrid) - University Hospitals

• 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.

• 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.

• Bachelor's Degree and some related experience (Required) or
• Associate's Degree with 4 years of clinical and/or research experience (Required)

• Ability to prioritize the work of multiple projects. (Required proficiency)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Write and edit technical documents. (Required proficiency)
• Ability to understand and communicate regulatory requirements to others. (Required proficiency)
• Medical terminology. (Required proficiency)
• Excellent verbal, written, interpersonal skills. (Required proficiency)

• Standing Occasionally
• Walking Occasionally
• Sitting Constantly
• Lifting Rarely 20 lbs
• Carrying Rarely 20 lbs
• Pushing Rarely 20 lbs
• Pulling Rarely 20 lbs
• Climbing Rarely 20 lbs
• Balancing Rarely
• Stooping Rarely
• Kneeling Rarely
• Crouching Rarely
• Crawling Rarely
• Reaching Rarely
• Handling Occasionally
• Grasping Occasionally
• Feeling Rarely
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Frequently
• Eye/Hand/Foot Coordination Frequently

• 10%

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