Sr. Clinical Research Associate
Description
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.
Additional Details:
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
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at
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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#LI-Remote
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.
Skills
As published by greenhouse · 24 questions · 1 written answer
Basics
First Name, Last Name, Preferred First Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (8)
- LinkedIn Profile optional
- Please list your street address.
- Please list your city.
- What is your desired hourly wage? optional
- Please list your zip/postal code.
- Please list your state.
- What is your desired salary?
- If an employee of CareDx referred you, please list their full name. optional
Pick from a list (15)
- All positions at CareDx require an in-person interview. Please confirm you read this statement.
- How many years of experience do you have working in clinical research?
- Have you independently conducted all phases of clinical trial site monitoring (selection, initiation, interim, and close-out visits)?
- Do you have hands-on experience working in compliance with ICH/GCP and FDA regulations in clinical trials?
- Are you willing and able to travel up to 75% as required for this role?
- Do you have a Bachelor’s degree or higher in a biomedical science or related field?
- Are you authorized to work in the U.S.?
- In the future, will you need sponsorship to work in the U.S. (for example, are you currently on an F-1, OPT, H-1B, TN, J-1, CPT, or other work visa)?
- If hired, can you submit verification of your legal right to work in the U.S.?
- Have you previously worked for CareDx, in any capacity?
- Are you over the age of 18 years?
- If under 18 years of age, do you have a work permit? optional
- May we contact you about future opportunities at CareDx? optional
- Are you open to relocation? optional
- Has an employee of CareDx referred you? optional
Written answers (1)
- Please provide three (3) professional references. We do not contact references until a candidate is near the offer stage. You will be notified before references are contacted.