Clinical Research Specialist II, Orthopedic

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
• Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF). (20%; Competency 1, 2)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)
• Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
• Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
• Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)

• 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.