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Sr. Clinical Research Associate jobs in United States
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CareDx, Inc. · 2 weeks ago

Sr. Clinical Research Associate

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated healthcare solutions for transplant patients. We are seeking a highly skilled and motivated Senior Clinical Research Associate to join our Clinical Operations team, ensuring the integrity, quality, and compliance of our clinical trials.
BiotechnologyHealthcareMedical DeviceInformation TechnologyHealth CareHealth Diagnostics
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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

Qualification

Clinical ResearchClinical Practice (GCP)FDA RegulationsISO StandardsElectronic Data Capture (EDC) SystemsClinical Trial Management Systems (CTMS)Medical TerminologyClinical Trial ProcessesClinical Study ManagementClinical ProgrammingData ValidationStandard Operating Procedures (SOPs)

Required

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

Preferred

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
And more!
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

Company

CareDx, Inc.

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CareDx, Inc., headquartered in South San Francisco, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

Funding

Current Stage
Public Company
Total Funding
$589.89M
Key Investors
Bristol-Myers SquibbSprout Group
2021-01-21Post Ipo Equity· $164M
2020-06-09Post Ipo Equity· $117.1M
2018-11-13Post Ipo Equity· $52.8M

Leadership Team

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John Hanna
Chief Executive Officer
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Keith Kennedy
Chief Operating Officer
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Company data provided by crunchbase