Sr. Clinical Research Associate

Wwshemi; California; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Base salary + incentives

Health benefits and welfare

Gym reimbursement

Job summary

CareDx, Inc. in Brisbane, CA seeks a Senior Clinical Research Associate to join our Clinical Operations team. You will oversee site visits, ensure protocol adherence, and maintain data integrity across trials.

This role emphasizes regulatory compliance, cross-functional collaboration, and leadership within a fast-paced biotech environment. The ideal candidate has 5+ years in clinical research, knowledge of ICH/GCP, FDA norms, and EDC/CTMS proficiency, with willingness to travel up to 75%.

Qualifications

• Bachelor’s degree or higher in biomedical sciences or related field.
• 5+ years of clinical research experience.
• Strong knowledge of GCP, FDA regulations, and ISO standards.
• Proficiency in EDC systems, CTMS, and Microsoft Office.
• CCRC or CCRA certification is a plus.
• Ability to travel up to 75%.

Responsibilities

• Conduct and oversee site visits to ensure protocol adherence and data quality.
• Collaborate with PIs, study coordinators, and cross-functional teams.
• Ensure compliance with ICH/GCP, IRB requirements, and monitoring plans.
• Identify and resolve data issues in EDC systems.
• Review data queries and reconcile listings and discrepancies.
• Maintain accurate study documentation and files.
• Lead study team meetings and contribute to protocols.
• Support site recruitment and oversight of enrollment goals.
• Mentor junior CRAs and provide technical data validation guidance.
• Assist in SOPs, workflows, and template development.
• Partner with Clinical Trials Manager on timelines and budgets.
• Liaise with regulatory authorities and CROs as needed.
• Ensure timely monitoring reports and follow-up letters.
• Monitor site performance metrics and cross-functional communication.

Skills

GCP knowledge

FDA regulations

Data management

Project management

Cross-functional collaboration

Education

Bachelor’s degree in biomedical sciences or related field

Tools

EDC systems

CTMS

Microsoft Office

Job description

CareDx, Inc. Brisbane, CA

This listing's locations Brisbane, CA

Employment Full-time

Compensation USD 100000–130000 (period not stated)

Department: RESEARCH & DEVELOPMENT

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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.

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

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This is the anticipated base salary range in the United States. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.