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 supporting clinical trial site management and oversight of assigned clinical studies in compliance with protocol, ICH-GCP, applicable regulatory requirements, and company SOPs. This role plays a critical part in ensuring site readiness, data integrity, patient safety, and oversight of CRO CRA monitoring activities and external vendors in a highly complex clinical environment involving advanced therapies.
The ideal candidate has sponsor-side clinical operations experience in early to late phase clinical trials and is comfortable operating in fast-paced, evolving biotech settings.
Title: Clinical Research Associate
Location: Remote with West Coast hours preferred
Reports to: Associate Director, Clinical Operations
Responsibilities
- Support site initiation, ongoing site management, and close-out activities in accordance with sponsor oversight plans and study timelines.
- Ensure clinical trial conduct complies with study protocol, ICH-GCP, FDA and global regulatory requirements, and company SOPs.
- Participate in data review and data cleaning activities to support data snapshots, as assigned.
- Review site status, enrollment progress, data trends, and action items to support efficient trial execution and escalate issues in a timely manner to the study lead and oversight director
- Provide oversight of CRO CRAs, participate in co-monitoring
- Provide oversight of CRO site management activities
- Maintain a compliant and contemporaneous study Trial Master File. Responsible for ensuring documents are filed correctly and timely, provide oversight of the CRO TMF management activities
- Perform regular TMF review and QC checks to ensure TMF health
- Participate in protocol deviation review and management of PDs
- Contribute to authoring and review of study documents and training materials
- Support site readiness and issue resolution through ongoing follow-up and communication with study sites
- Partner with patient operations to support certain cell therapy logistics operations, as needed
- Participate in the review monitoring reports, follow-up letters, and site action plans prepared by CRO CRAs and support issue resolution as needed.
- Support inspection readiness activities and support the team in regulatory inspections or audits as needed.
- Support metrics review and feedback for assigned clinical trials.
- Identify and escalate site compliance issues, protocol deviations, and patient safety concerns.
- Partner with cross-functional study team members on ongoing study activities and contribute to study team meetings
- Build strong relationships with clinical trial sites and serve as the sponsor point of contact for site staff
Qualifications
- Bachelor's degree in life sciences, nursing, or a related field required; advanced degree preferred.
- Minimum of 3+ years of clinical operations experience in biotech, pharma, or CRO environments. Must have Sponsor side experience.
- Prior experience supporting site management, CRO oversight, or co-monitoring activities strongly preferred.
- Prior experience monitoring cell therapy, gene therapy, immunology, or other complex therapeutic areas 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 preferred.
- 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 $95,000 to $115,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this 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 plan.
Top Skills
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
