- Prepare all regulatory submissions- Initial IRB application, continuing reviews, amendments, safety report forms, FDA IND/IDE submissions and reports
- Develop study forms, such as Informed Consent (ICF), Subject Assent, Parental Permission (PPF), etc.
- Maintain regulatory study binders according to sponsor and federal regulatory requirements
- Ensure study compliance with University of Utah policy and federal regulations by the following agencies:
o U.S. Department of Health and Human Services (DHHS)
o U.S. Food and Drug Administration (FDA)
o Office for Human Research Protections (OHRP)
o Institutional Review Board (IRB)
Maintain International Council for Harmonisation (ICH) Good Clinical Practice (GCP) requirements and compliance with principles of human subject protection in the Declaration of Helsinki and the Nuremberg Code
Clinical Research Coordinators (CRC)
- Perform study protocol activities, such as obtaining informed consent, reporting and tracking adverse events (AEs), serious adverse events (SAEs) and protocol deviations, completing case report forms (CRFs), sample collection, overseeing sample processing and shipping, etc.
- Mentor junior coordinating staff
- Coordinate sponsor monitoring visits
- Achieved industry standard certification (ACRP and/or SOCRA)
Study Coordinators (SC)
- Perform study protocol activities, such as obtaining informed consent, reporting and tracking adverse events (AEs), serious adverse events (SAEs) and protocol deviation, completing case report forms (CRFs), sample collection, sample processing and shipping, etc.
- Screen applicants, coordinate study visits and sponsor monitoring visits
Research Assistants (RA)
- Provide research support, including data entry, participant screening, coordinating study visits, sample processing and shipping, etc.
- Obtain informed consent in non-drug research studies