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Sr. Clinical Research Associate
<div class="content-intro"><p><span style="font-family: times new roman, times, serif;"><span style="font-size: 16px;"> </span></span></p></div><p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Conduct and oversee all types of site visits (e.g., selection, initiation, interim, close-out) to ensure protocol adherence, patient safety, and data accuracy.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Collaborate with Principal Investigators, study coordinators, and cross-functional teams to drive study success.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Identify and resolve data collection issues within electronic data capture (EDC) systems.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Review and reconcile data queries, listings, and discrepancies.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Maintain accurate and complete study documentation and files.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Lead study team meetings and contribute to protocol development and amendments.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Support site recruitment and provide oversight to ensure enrollment goals are met.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Mentor junior CRAs and provide technical expertise in clinical programming and data validation.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Assist in the development and refinement of SOPs, workflows, and templates.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Partner with Clinical Trials Manager to manage timelines, budgets, and resources.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Liaise with regulatory authorities and CROs as needed.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Monitor site performance metrics and facilitate effective communication across stakeholders.</span></li> </ul> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Qualifications</strong></span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Bachelor’s degree or higher in biomedical sciences or a related field.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">5+ years of experience in clinical research within biotech, pharma, medical device, or academia.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Strong knowledge of GCP, FDA regulations, and ISO standards.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Proficiency in EDC systems, CTMS, and Microsoft Office Suite.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Certification (CCRC or CCRA) is a plus.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Excellent understanding of medical terminology and clinical trial processes.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Proven ability to manage multiple studies and priorities with precision and urgency.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Exceptional communication, organizational, and interpersonal skills.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Demonstrated ability to work independently and collaboratively in remote, cross-functional teams.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ability to travel up to 75% of the time.</span></li> </ul> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>What You Bring</strong></span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">A proactive mindset and high standards for quality and accuracy.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Strong analytical and problem-solving skills.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ability to adapt quickly to changing demands and environments.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">A customer-focused approach in working with sites and external partners.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">A commitment to continuous improvement and operational excellence.</span></li> </ul> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Additional Details: </strong></span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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. </span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Our competitive Total Rewards package for US Employees includes: </span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Competitive base salary and incentive compensation</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Health and welfare benefits, including a gym reimbursement program</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">401(k) savings plan match</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Employee Stock Purchase Plan</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Pre-tax commuter benefits</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">And more!</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Please refer to our page to view detailed benefits at <a class="Hyperlink SCXW16398972 BCX8" href="https://caredx.com/company/careers/" target="_blank"><span class="TextRun Underlined SCXW16398972 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW16398972 BCX8" data-ccp-charstyle="Hyperlink">https://caredx.com/company/careers/</span></span></a></span></li> </ul> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong><em>CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.</em></strong></span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong><em>By proceeding with our application and submitting your information, you acknowledge that you have read our </em></strong><strong><em><a href="https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fcaredx.com%2Fus-personnel-privacy-notice%2F&data=05%7C02%7C%7C82daf31a87e44746b2ea08dceef5e348%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C638647987067912610%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2m6s48ae9FuUbrhudLltyYwmxkwF09q91VSr94Shslg%3D&reserved=0" target="_blank">U.S. Personnel Privacy Notice</a><a href="https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fcaredx.com%2Fus-personnel-privacy-notice%2F&data=05%7C02%7C%7C82daf31a87e44746b2ea08dceef5e348%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C638647987067924758%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=fvNqQdyyA0YaWb3Y4bxHjbbzsxfJ4EmKAEMFQr39KnU%3D&reserved=0" target="_blank"> </a></em></strong><strong><em>and consent to receive email communication from CareDx.</em></strong></span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><em><strong>***We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.***</strong></em></span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our <a href="https://caredx.com/privacy-center/#ca-privacy">Privacy Policy</a>.</strong></span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">#LI-Remote</span></p> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><span style="font-size: 16px;">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.</span></p></div><div class="title">Remote: US only roles</div><div class="pay-range"><span>$100,000</span><span class="divider">—</span><span>$130,000 USD</span></div></div></div>