Clinical Research Regulatory Specialist I - Urology
- Full-Time
- Cleveland, OH
- University Hospitals
- Posted 2 years ago – Accepting applications
Job Description
Description
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- 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.
- Completion of a bachelors degree and some related experience or associates degree with 4 years of clinical and or research experience required.