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Senior Clinical Research Associate

Job not on LinkedIn

🔥 12 hours ago

🏄 California – Remote

infoinfo

đź’µ $100k - $130k / year

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

Where this job comes from

Posted on CareDx, Inc.'s careers page, not through a job board

First seen by Remote Rocketship 12 hours ago

Still open on CareDx, Inc.'s site. Checked 5 minutes ago.

Logo of CareDx, Inc.

CareDx, Inc.

501 - 1000 employees

🏥 Healthcare

đź’Ľ Consulting

📦 Logistics

Healthcare • Consulting • Logistics

<CareDx, Inc. > CareDx, Inc. is a healthcare-focused company that develops diagnostic tests, laboratory services, and digital solutions specifically for transplant patients and providers. Its offerings include cell-free DNA tests (AlloSure) for monitoring organ injury, HLA typing products for matching, transplant lab services, digital patient management apps and EMR integrations, and pharma services to support clinical development. CareDx serves transplant centers, clinicians, patients, and biopharma partners to improve organ transplant outcomes across kidney, heart, and lung care.

đź“‹ Description

• Conduct and oversee site visits, including selection, initiation, interim, and close-out visits • Collaborate with Principal Investigators, study coordinators, and cross-functional teams • 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 goals • Mentor junior CRAs and provide technical expertise in clinical programming and data validation • Develop and refine SOPs, workflows, and templates • Partner with the Clinical Trials Manager on timelines, budgets, and resources • Liaise with regulatory authorities and CROs • Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters • Monitor site performance metrics and facilitate communication across stakeholders

🎯 Requirements

• 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 • A proactive mindset and high standards for quality and accuracy • Strong analytical and problem-solving skills • Ability to adapt quickly to changing demands and environments • A customer-focused approach in working with sites and external partners • A commitment to continuous improvement and operational excellence

🏖️ Benefits

• 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 • Up to 30 days of paid leave annually for a full-time employee who donates an organ or bone marrow • Additional discretionary bonuses/incentives and restricted stock units may be available

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