Position Summary

Under the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned clinical research trials:

Essential Functions

• Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10% Competency 1,2)
• Performs assigned 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 source documents and case reporting forms. (30% Competency 1,2)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20% 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)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10% Competency 3)
• Performs other related duties as assigned or required. (10%; Competency 1, 2,3)

Required For All Jobs

• 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.