Job Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Position Summary
The Clinical Research Associate (CRA) is responsible for the monitoring and oversight of clinical trial sites conducting cell therapy clinical studies in compliance with protocol, ICH-GCP, applicable regulatory requirements, and company SOPs. This role plays a critical part in ensuring data integrity, patient safety, and site readiness in a highly complex clinical environment involving advanced therapies.
The ideal candidate has hands-on monitoring experience in early-phase to late-phase clinical trials and is comfortable operating in fast-paced, evolving biotech settings.
Title: Clinical Research Associate
Location: Remote
Reports to: Sr. Director, Clinical Operations
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.
Cell Therapy–Specific Responsibilities
- 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.
Safety & Quality Oversight
- 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.
CRO/Vendor Relationship Management
- 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
Site Relationship Management
- 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.
Cross-Functional Collaboration
- 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.
Qualifications
- Bachelor’s degree in life sciences, nursing, or a related field required; advanced degree preferred.
- Minimum of 3+ years of clinical monitoring experience as a CRA in biotech, pharma, or CRO environments.
- Prior experience monitoring cell therapy, gene therapy, immunology, or other complex therapeutic areas strongly preferred.
- Prior experience working as a CRA on the sponsor side (biotech or pharmaceutical company) strongly preferred
- 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.
- Prior inspection or audit support experience.
- Familiarity with decentralized or hybrid trial models.
- Exceptional attention to detail and organizational skills.
- Strong written and verbal communication skills.
- Ability to manage multiple sites and priorities independently.
The national salary range for this position is from $90,000 to $115,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
