Clinical Trials Associate - T45 Labs

Clinical Trials Associate - T45

Labs Status:

Full-time, Non-exempt Location:

Onsite, Santa Clara, CA Reports to: Sr. Clinical Trials Manager About the Company 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. About the Role 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. Key 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 Required Experience and Qualifications 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 Preferred Qualifications 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 Eligibility Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas, or permanent residency (PERM) applications. Location and Compensation This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available. T45 Labs is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package. Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired. The anticipated rate of pay of this position is $38 per hour. Equal Employment Opportunity T45 Labs is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Third-Party Recruiter Notice T45 Labs does not accept unsolicited resumes from agencies. Any resumes submitted without a signed agreement will be considered the property of T45 Labs and no fees will be paid. Agencies interested in submitting candidates may email careers@t45labs.com