- San Diego, California, United States
- Contract
- $73K–$89K per year
- 2+ years
Responsible for ensuring regulatory compliance for multi-center clinical trials managed by the ATRI.
Compensation
The annual base salary range for this position is $73,092.61 - $89,042.90.
Responsibilities
- Review site-specific informed consent forms for consistency with the protocol, approved study templates, regulatory requirements, and study procedures.
- Preparation of Investigator Initiation Packages (IIPs) for distribution to clinical trial sites.
- Initiate IRB submission through USC iStar system and Advarra IRB (central IRB) for ATRI clinical trials.
- Tracking study start-up activities for multi-center clinical trials and providing regular updates to Project Directors, Sponsors and ATRI Leadership.
- Distribution, collection, processing and tracking of Essential Site Regulatory Documents for ongoing ATRI clinical trials, including collection of updated Investigator CVs, licenses, GCP and human subjects training certificates.
Requirements
- Bachelor's degree
- Nice to have: Experience with FDA, GCP and OHRP
- Nice to have: Previous regulatory experience
- Nice to have: Previous experience with eTMF systems
- Nice to have: Proficiency in Microsoft Office