Note: The job is a remote job and is open to candidates in USA. CareDx, Inc. is a leading precision medicine solutions company focused on improving healthcare solutions for transplant patients. They are seeking a highly skilled Senior Clinical Research Associate to ensure the integrity, quality, and compliance of clinical trials, while mentoring junior team members and collaborating with cross-functional teams.
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
Skills
- 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
- 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
- Certification (CCRC or CCRA) is a plus
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
- 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
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