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. 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).
What You Will Do
Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. 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.
Why It Might Be a Fit
Must have ability to prioritize the work of multiple projects, knowledge of GCP and FDA guidelines, and ability to train and mentor junior staff.
Requirements
- Bachelor's Degree
- 2+ years clinical research experience
- Experience in a team setting
- Certification in Human Subjects Protection (CITI) within 30 Days
- Society of Clinical Research Associates (SoCRA) or ACRP Certified Professional (ACRP-CP) certification
Benefits
- 10% Travel may be required
- 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
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