Clinical Trials Associate - T45 Labs
T45 Labs•Santa Clara, CA
•$38•Onsite
About The Position
We are seeking a Clinical Trials Associate (CTA) to support clinical operations activities across multiple medical device programs. This role is focused on coordination, documentation, and day-to-day execution of clinical studies. You will work closely with Clinical Affairs, CRAs, and external partners to help keep studies organized, compliant, and moving forward. This is a strong fit for someone who is detail-oriented, highly organized, and comfortable working in a fast-paced, start-up environment with evolving priorities.
Requirements
- Bachelor’s degree in life sciences, public health, healthcare, or a related field
- 1–3 years of experience in clinical research, preferably in a medical device environment
- Familiarity with GCP, FDA regulations, and ISO 14155 for device trials
- Strong organizational skills and attention to detail
- Strong written and verbal communication skills
- Ability to work onsite and collaborate in a fast-paced, cross-functional, start-up environment
Nice To Haves
- Experience supporting cardiovascular or catheter-based medical device studies
- Familiarity with eTMF systems, CTMS platforms, or device accountability workflows
- Prior experience with TMF management, study coordination, or site support activities
- Exposure to early feasibility, first-in-human, or early-stage device trials
Responsibilities
- Support clinical study activities to ensure compliance with protocols, SOPs, FDA regulations, and ICH/GCP guidelines
- Assist with site communication, meeting scheduling, agendas, and follow-up tracking
- Support regulatory document collection, site start-up activities, and IRB/EC submissions
- Maintain proactive communication with investigational sites, CROs, vendors, and internal team members
- Maintain, audit, and reconcile Trial Master File (TMF/eTMF) documentation to ensure accuracy, completeness, and inspection readiness
- Develop and maintain study trackers, logs, and operational tools
- Support investigational product documentation, shipment tracking, and reconciliation activities
- Participate in document review, quality checks, and audit support activities
- Partner with CTMs, CRAs, Clinical Affairs leadership, and external vendors
- Support data reconciliation and coordinate resolution of queries with sites, CROs, and monitors
- Participate in internal study meetings and provide updates and logistical support
- Assist in preparing study documentation for early feasibility and future pivotal trials
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
