Kyverna Therapeutics · 1 day ago
Clinical Research Associate
United States
Full-time
Remote
Mid Level
$90K/yr - $115K/yr
3+ years expKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Clinical Research Associate (CRA) is responsible for monitoring and overseeing clinical trial sites to ensure compliance with protocols and regulatory requirements while ensuring data integrity and patient safety.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Site Monitoring & Trial Execution
Ensure site qualification, initiation, routine monitoring, and close-out visits are performed in accordance with monitoring plans and study timelines
Ensure clinical trial conduct complies with study protocol, ICH-GCP, FDA and global regulatory requirements, and company SOPs
Verify informed consent process and documentation for all study participants
Conduct source data verification (SDV) and source data review (SDR) to ensure data accuracy and completeness
Review and resolve data queries in collaboration with sites and data management
Monitor chain of identity (COI) and chain of custody (COC) processes related to cell collection, manufacturing, shipping, and administration
Ensure compliance with protocol requirements for product handling, storage, and administration
Monitor coordination between CRO/vendors, clinical sites, apheresis centers, manufacturing facilities, and logistics vendors
Ensure proper documentation and reporting of product deviations, excursions, and handling issues
Ensure timely and accurate reporting of adverse events (AEs, SAEs), and special safety events per protocol and regulatory requirements
Identify and escalate site compliance issues, protocol deviations, and patient safety concerns
Support inspection readiness activities and participate in regulatory inspections or audits as needed
Support metrics review and feedback for assigned clinical trials
Contribute to strong, collaborative relationships with CRO / vendor partners
Track and support CRO / vendor performance, enrollment and data management efforts
Contribute to a high-quality Trial Master File (TMF) and support audit preparation efforts as needed
Serve as the primary point of contact for assigned clinical trial sites
Build strong, collaborative relationships with investigators, study coordinators, and site staff
Provide training and ongoing support to sites on protocol requirements, amendments, and study procedures
Track and support site performance, enrollment, and retention efforts
Partner closely with Clinical Development, Data Management, Regulatory Affairs, Quality, and vendors
Provide timely and accurate site status updates and feedback on CRO monitoring reports
Contribute to study team meetings and risk-based monitoring discussions
Qualification
Required
Bachelor's degree in life sciences, nursing, or a related field required
Minimum of 3+ years of clinical monitoring experience as a CRA in biotech, pharma, or CRO environments
Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
Experience with EDC systems, CTMS, eTMF, and safety reporting processes
Familiarity with risk-based monitoring approaches
Exceptional attention to detail and organizational skills
Strong written and verbal communication skills
Ability to manage multiple sites and priorities independently
Preferred
advanced degree
Prior experience monitoring cell therapy, gene therapy, immunology, or other complex therapeutic areas
Prior inspection or audit support experience
Familiarity with decentralized or hybrid trial models
Benefits
Bonus
Benefits
Participation in Company’s stock option plan
Company
Kyverna Therapeutics
Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.
51-200 employees
H1B Sponsorship
Kyverna Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$295MKey Investors
Oxford Finance LLCNorthpond Ventures
2025-12-17Post Ipo Equity· $100M
2025-11-03Post Ipo Debt· $25M
2024-02-08IPO
Leadership Team
Marc Grasso
Chief Financial Officer
Tom Van Blarcom
Senior Vice President, Head of Research
Recent News
2026-01-16
Company data provided by crunchbase