17 days ago
Title- Sr. Clinical Trial Associate/ Clinical Research Associate- San Francisco Bay Area- Oncology focused
Our client requires a Sr. Clinical Trial Associate for a growing biotech based in the San Francisco Bay Area.
This is an opportunity for an experienced CTA who wants to grow within the business and have the opportunity to function at a higher level with mentorship in a fast-paced start-up environment. The ideal candidate will be involved with developing and creating best practices and process development.
- Develop a strong understanding of clinical study protocols.
- Prepares, handles, distributes, files and archives clinical documentation and reports.
- Independently maintains the internal Trial Master File (eTMF) in accordance with the DIA’s reference model and periodically reviews (QC’s) to ensure accuracy and completeness.
- Independently and proactively maintains and updates the CTMS (Clinical Trial Management System) with site information, study contacts, regulatory documents, CRA IMV visits, tracking of IMV reports and runs reports as requested.
- Work with the Clinical Research Associates on monitoring of data including query resolution, as needed.
- Bachelor’s degree preferably in the areas such as biological science, health care management, life sciences or nursing
- Understanding of the eTMF structure and regulatory document requirements for site activation
- Understanding of the drug development process, GCP and ICH standards
- Experience with CTMS (preferably Simple Trials)
- Experience with medical devices
If you are interested in this opportunity, please send a copy of your resume to firstname.lastname@example.org