CareDx, 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. CareDx offers products, testing services, and digital healthcare solutions along the pre‐ and post‐transplant patient journey, and is the leading provider of genomics‐based information for transplant patients.
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. The ideal candidate will bring deep expertise in clinical study management, a passion for improving patient outcomes, and the ability to lead and mentor within a fast‐paced, collaborative environment.
Key Responsibilities
* Conduct and oversee all types of site visits (e.g., 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.
Qualifications
* Education: Bachelor's degree or higher in biomedical sciences or a related field.
* Experience: 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.
What You Bring
* 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 Total Rewards package for US Employees includes:
* Competitive base salary and incentive compensation
* Health and welfare benefits, including a gym reimbursement program
Remote: US only roles
$100,000 - $130,000 USD
CareDx, Inc. is an Equal Opportunity Employer and participates in the E‐Verify program.
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