Sr. Clinical Research Associate

CareDx, Inc.•Brisbane, CA
•$100,000 - $130,000•Remote

About The Position

CareDx is seeking a highly skilled and motivated Senior Clinical Research Associate to join its Clinical Operations team. The role supports the integrity, quality, and compliance of clinical trials and calls for expertise in clinical study management, a commitment to improving patient outcomes, and the ability to lead and mentor in a fast-paced, collaborative environment. This is a remote role open to candidates in the United States, with travel of up to 75% of the time. The Senior Clinical Research Associate oversees clinical site visits and works with investigators, study coordinators, internal teams, CROs, and regulatory authorities to support successful study execution. The role covers protocol compliance, patient safety, data quality, site recruitment and performance, study documentation, monitoring reports, and operational processes. It also partners with the Clinical Trials Manager on timelines, budgets, and resources and contributes to protocol development, study-team leadership, and mentoring junior CRAs. CareDx describes its US employee Total Rewards package as including competitive base salary and incentive compensation, health and welfare benefits, a gym reimbursement program, a 401(k) savings plan match, an Employee Stock Purchase Plan, and pre-tax commuter benefits. Full-time employees may also receive up to 30 days of paid leave annually under the Living Donor Employee Recovery Policy for donating an organ or bone marrow. The anticipated US base salary range is $100,000–$130,000; the final offer depends on factors including experience and education. The role may also be eligible for discretionary bonuses or incentives and restricted stock units.

Requirements

  • Bachelor’s degree or higher in biomedical sciences or a related field.
  • At least 5 years of clinical research experience in biotech, pharmaceutical, medical device, or academic settings.
  • Strong knowledge of GCP, FDA regulations, and ISO standards.
  • Proficiency in EDC systems, CTMS, and Microsoft Office Suite.
  • Excellent understanding of medical terminology and clinical trial processes.
  • Ability to manage multiple studies and priorities with precision and urgency.
  • Exceptional communication, organizational, and interpersonal skills.
  • Ability to work independently and collaboratively in remote, cross-functional teams.
  • Ability to travel up to 75% of the time.
  • Proactive mindset and high standards for quality and accuracy.
  • Strong analytical and problem-solving skills.
  • Ability to adapt quickly to changing demands and environments.
  • Customer-focused approach when working with sites and external partners.
  • Commitment to continuous improvement and operational excellence.

Nice To Haves

  • CCRC or CCRA certification.

Responsibilities

  • Conduct and oversee site selection, initiation, interim, and close-out visits 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 in 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 oversee enrollment progress toward study goals.
  • Mentor junior CRAs and provide technical expertise in clinical programming and data validation.
  • Assist in developing and refining SOPs, workflows, and templates.
  • Partner with the Clinical Trials Manager to manage timelines, budgets, and resources.
  • Liaise with regulatory authorities and CROs as needed.
  • Ensure timely and compliant completion of monitoring reports, trip reports, and follow-up letters.
  • Monitor site performance metrics and facilitate communication among stakeholders.

Benefits

  • Competitive base salary and incentive compensation.
  • Health and welfare benefits.
  • Gym reimbursement program.
  • 401(k) savings plan match.
  • Employee Stock Purchase Plan.
  • Pre-tax commuter benefits.
  • Up to 30 days of paid leave annually for eligible full-time employees who donate an organ or bone marrow under the Living Donor Employee Recovery Policy.
  • Potential eligibility for discretionary bonuses or incentives and restricted stock units.
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