Job Description

Status: Full-time, Exempt

Reports to: Director of Clinical Operations

Role Summary

T45 Labs is seeking a Sr. 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 medical device 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 a plus), or equivalent experience in medical device trials (cardiovascular medical devices highly 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

The position is open to candidates who live within a reasonable commute distance of our Santa Clara office. To support in-person collaboration and team activities, candidates are expected to work on site in Santa Clara 5 days per week.

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 $137,000 - $186,000 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 [email protected].

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