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

• Bachelors degree in life sciences public health healthcare or a related field
  
• 13 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

Required Experience:

IC