Sr. Clinical Research Associate

Senior Clinical Research Associate

Care Dx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers.

We are seeking a highly skilled and motivated Senior Clinical Research Associate to join our Clinical Operations team. This role is pivotal in ensuring the integrity, quality, and compliance of our clinical trials.

• Conduct and oversee all types of site visits (selection, initiation, interim, close–out) to ensure protocol adherence, patient safety, and data accuracy.
• Collaborate with Principal Investigators, study coordinators, and cross‑functional teams to drive study success.
• Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans.
• Identify and resolve data collection issues within electronic data capture (EDC) systems.
• Review and reconcile data queries, listings, and discrepancies.
• Maintain accurate and complete study documentation and files.
• Lead study team meetings and contribute to protocol development and amendments.
• Support site recruitment and provide oversight to ensure enrollment goals are met.
• Mentor junior CRAs and provide technical expertise in clinical programming and data validation.
• Assist in the development and refinement of SOPs, workflows, and templates.
• Partner with Clinical Trials Manager to manage timelines, budgets, and resources.
• Liaise with regulatory authorities and CROs as needed.
• Ensure timely and compliant execution of monitoring reports, trip reports, and follow‑up letters.
• Monitor site performance metrics and facilitate effective communication across stakeholders.

• Bachelor’s degree or higher in biomedical sciences or a related field.
• 5+ years of experience in clinical research within biotech, pharma, medical device, or academia.
• Strong knowledge of GCP, FDA regulations, and ISO standards.
• Proficiency in EDC systems, CTMS, and Microsoft Office Suite.
• Certification (CCRC or CCRA) is a plus.
• Excellent understanding of medical terminology and clinical trial processes.
• Proven ability to manage multiple studies and priorities with precision and urgency.
• Exceptional communication, organizational, and interpersonal skills.
• Demonstrated ability to work independently and collaboratively in remote, cross‑functional teams.
• Ability to travel up to 75% of the time.

• Competitive base salary and incentive compensation.
• Health and welfare benefits, including a gym reimbursement program.
• 401(k) savings plan match.
• Employee Stock Purchase Plan.
• Pre‑tax commuter benefits.
• And more.

Every individual at Care Dx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We also offer a Living Donor Employee Recovery Policy that provides up to 30 days of paid leave annually for full‑time employees who donate an organ or bone marrow.

Base Salary (Remote, US): $90,000 – $117,000 USD.
San Francisco Bay Area
: $100,000 – $130,000 USD.

Care Dx, Inc. is an Equal Opportunity Employer and participates in the E‑Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from Care Dx.