Clinical Research Associate
Status: Full-time, Exempt
Reports to: Clinical Trials Manager
Role Summary
T45 Labs is seeking a Senior Clinical Research Associate (CRA) to independently manage site monitoring and clinical operations activities across a range of medtech clinical trials. This individual will be responsible for overseeing site performance, ensuring regulatory compliance, and supporting cross-functional trial execution. The ideal candidate will have 5+ years of experience in clinical research, including direct monitoring of investigational sites, and will bring a deep understanding of FDA, ICH-GCP, and ISO 14155 standards, ideally with a background in medical device trials.
Responsibilities
Site Monitoring & Oversight
- Independently perform site qualification, initiation, monitoring, and close-out visits, ensuring compliance with the protocol, GCP, and applicable regulations.
- Ensure source data verification (SDV), informed consent processes, and IP accountability are maintained at each site.
- Serve as the main point of contact for investigative sites, providing guidance and support to ensure optimal site performance.
- Proactively identify and address protocol deviations, data discrepancies, and site challenges.
- Ensure all site documentation is current, complete, and audit-ready within the Trial Master File (TMF).
Clinical Operations Support
- Contribute to the development and review of trial documents such as protocols, case report forms (CRFs), monitoring plans, and ICFs.
- Draft and submit monitoring visit reports and follow-up communications in a timely and accurate manner.
- Collaborate with Clinical Operations leadership to ensure project timelines, enrollment targets, and quality metrics are met.
- Assist in preparation for regulatory audits and inspections.
Cross-Functional Collaboration
- Work closely with Project Management, Regulatory, Data Management, and Quality teams to ensure smooth trial execution.
- Contribute to investigator meetings, site training sessions, and internal clinical team discussions.
- Provide mentoring or informal support to junior CRAs or Clinical Trial Associates.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree or certification preferred).
- 5+ years of clinical research experience, including independent site monitoring responsibilities.
- Strong knowledge of FDA, ICH-GCP, ISO 14155, and applicable clinical research regulations.
- Demonstrated experience with medical device clinical trials preferred.
- Proficient in CTMS, EDC, and eTMF systems; strong documentation and reporting skills.
- Excellent interpersonal, organizational, and problem-solving skills.
- Ability and willingness to travel up to 35%, including in-person site visits as required.
Location & Compensation
This position is open to remote candidates; however, preference will be given to applicants located in the San Francisco Bay Area. Candidates based in the Bay Area are generally expected to work in our Santa Clara office at least one day per week to support in-person collaboration and team activities.
T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.
The anticipated salary range for this position is $122,000 - $166,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, skills, and geographic location.
Third-Party Recruiter Notice
We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com.
Average salary estimate
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If you're an experienced Clinical Research Associate (CRA) looking to take the next step in your career, T45 Labs is the place for you! We're on the hunt for a Senior Clinical Research Associate to join our dynamic team, ideally suited for someone with 5+ years of experience in clinical research. This is a fantastic opportunity to independently manage site monitoring and clinical operations for various medtech clinical trials remotely. In this role, you will oversee site performance, ensure regulatory compliance, and support cross-functional trial execution. You’ll be the main point of contact for investigative sites, performing tasks such as site qualification, initiation, monitoring, and close-out visits. At T45 Labs, we pride ourselves on fostering a collaborative environment, and you will be working closely with our Project Management, Regulatory, Data Management, and Quality teams. A solid knowledge of FDA regulations, ICH-GCP, and ISO 14155 standards is crucial, along with familiarity in medical device clinical trials. If you enjoy mentoring and supporting junior team members while maintaining high standards of quality and compliance in clinical trials, then we'd love to see you apply! This remote position allows for flexibility, although we do prefer candidates based in the San Francisco Bay Area for occasional in-person collaboration. Join us at T45 Labs and be a vital part of our mission to improve healthcare through innovative research!
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