Position Summary/Essential Duties:
Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials:
1. Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
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)
3. Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
4. 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)
5. Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
6. Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
7. Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
8. Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)
- Bachelor’s degree required and at least 2 years of clinical research experience. Research certification preferred (e.g., SOCRA or ACRP)
Experience & Knowledge:
o At least 2 years of clinical research experience required.
o Ability to prioritize the work of multiple projects.
o Experience in a team setting.
o Knowledge of GCP and FDA guidelines.
o Knowledge of Electronic Data Capture Programs.
o Medical & Research Terminology.
o DOT/IATA Training Preferred
UH Cleveland Medical Center
UH Cleveland Medical Center is University Hospitals’ flagship academic medical center. With more than 1,000 registered beds, UH Cleveland Medical Center provides primary, specialty and subspecialty medical and surgical care in the heart of Cleveland’s University Circle.