Senior Clinical Research Associate

CareDx, Inc.

. Conduct and oversee site visits, including selection, initiation, interim, and close-out visits .

Posted 11/4/2026full-timeRemote • California • United StatesSenior💰 $100,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research management, ensuring compliance with GCP, FDA regulations, and ISO standards while effectively collaborating with cross-functional teams. Proficient in EDC systems and capable of mentoring junior staff to uphold high standards of quality and operational excellence.

Highest-signal resume keywords

Clinical Research ManagementGCP ComplianceEDC Systems ProficiencyData Analysis and Problem-SolvingTeam Collaboration and Mentorship

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ProcessesData Collection and ReconciliationProtocol DevelopmentSOP DevelopmentStudy Documentation ManagementSite Performance MonitoringRegulatory LiaisonEnrollment ManagementBudget and Resource ManagementMedical Terminology

Soft Skills

Exceptional CommunicationOrganizational SkillsInterpersonal SkillsProactive MindsetAdaptability

Tools & Technologies

EDC SystemsCTMSMicrosoft Office Suite

Certifications & Qualifications

CCRCCCRA

Industry Keywords

BiotechPharmaMedical DeviceAcademiaICH Guidelines

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct and oversee site visits, including selection, initiation, interim, and close-out visits
Collaborate with Principal Investigators, study coordinators, and cross-functional teams
Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans
Identify and resolve data collection issues in 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 oversee enrollment goals
Mentor junior CRAs and provide technical expertise in clinical programming and data validation
Develop and refine SOPs, workflows, and templates
Partner with the Clinical Trials Manager on timelines, budgets, and resources
Liaise with regulatory authorities and CROs
Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters
Monitor site performance metrics and facilitate communication across stakeholders

Requirements

What you’ll need

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
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
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

Benefits

Comp & perks

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
Up to 30 days of paid leave annually for a full-time employee who donates an organ or bone marrow
Additional discretionary bonuses/incentives and restricted stock units may be available