Clinical Trials Associate - T45 Labs
About The Position
T45 Labs advances breakthrough cardiovascular technologies from early development into the clinic. We focus on selecting the right innovations, developing them with precision, and moving them through critical clinical and regulatory milestones so they reach the physicians and patients who need them most. 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
- Study Coordination and Site Support
- 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
- Documentation and Quality
- 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
- Cross-Functional Collaboration
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
