Clinical Trial Assistant
$56,704–$70,880 year
On-siteSan Francisco, California, United States
Job Summary
Lead the setup of electronic Trial Master File (eTMF) systems and manage clinical trial management systems, ensuring information updates align with ICH/GCP and sponsor SOPs. Support study teams from protocol development through archiving by overseeing monitoring visit reports, managing clinical supplies, and coordinating internal and external meetings. Draft TMF plans, lead quality checks, and facilitate finance activities including invoice processing and budget reconciliation for sites and vendors. Maintain communication platforms, compile clinical trial logs, and support data oversight efforts for SAEs and protocol deviations. Conduct overall TMF status management and guide document transfers during audits and regulatory inspections.
Required Qualifications
- High school or GED with four years relevant experience
- Bachelor's degree or above
- Life Sciences preferred
- Certification in a related health profession (i.e. nursing, medical or laboratory technology) from an accredited institution is preferred
- At least 1 year experience as a CTA, CRC, or other role in clinical trials
- Proven organizational and presentation skills
- Ability to manage multiple tasks with meticulous attention to detail
- Quick learner and team player
- Excellent written and verbal communication skills
- Computer proficiency in Microsoft Word, Excel, PowerPoint and Outlook
- Good knowledge of the ICH/GCP
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
- Position is on site 3-4 days a week at client office in South San Francisco, CA and days from home
Desired Qualifications
- Oncology experience a huge plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.