Role OverviewWorks 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.
What You Will Do
Performs all activities related to clinical research studies, including screening participants for eligibility, obtaining informed consent, educating participants regarding study requirements, and completing case report forms.
Why It Might Be a Fit
Requires in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines, as well as the ability to prioritize multiple projects, train and mentor junior staff, and communicate research protocol requirements to others.
Requirements
- Bachelor's Degree
- 2+ years clinical research experience
- Experience in a team setting
- Ability to prioritize the work of multiple projects
- Knowledge of GCP and FDA guidelines
- Knowledge of Electronic Data Capture Programs
- Medical & Research Terminology
- Certification in Human Subjects Protection (CITI)
- Certification in Society of Clinical Research Associates (SoCRA) or ACRP Certified Professional (ACRP-CP)
Benefits
- Annual training
- UH Code of Conduct
- UH policies and procedures
- Protected Health Information (PHI) training
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