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Senior Clinical Research Associate

4 months ago

Emeryville, United States Kyverna Therapeutics Full time

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated

Kyverna is recruiting an in house Senior Clinical Research Associate (CRA) in its Clinical organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what's next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.

Reporting to the Sr. Clinical Trial Manager, the Sr CRA will support the day-to-day operations of assigned Kyverna clinical trials, including start-up, conduct and close-out activities. The Sr. CRA may, under supervision, lead the day-to-day operations of clinical trials and will also ensure the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements. The successful candidate will be a highly organized individual who can multitask and adjust direction based on changing projects and priorities.

Responsibilities

    • Support the Clinical Trial Manager role in conduct of clinical trials.
    • Prepare agendas for, support, and minute the internal trial team meetings.
    • Serve as the primary contact for selected service providers.
    • Ensure assigned aspects of clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs.
    • As assigned, develop study specific documents, such as template informed consent documents, study plans or manuals, case report forms, and other study level documents
    • As assigned, assist in review of clinical documentation such as protocol, country- or site-specific informed consent documents, study plans or manuals, and other study level documents
    • Participate in RFP and vendor selection process.
    • Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with CRO.
    • Develop and deliver study training to study staff, and internal staff on study processes.
    • Liaise with the CRO and study site personnel to ensure timely and correct entry of data into CRF, including the timely resolution of data queries.
    • Assist with reviews of data listings, data coding, patient profiles, through the study and in preparation for database lock and site close-out activities.
    • Maintain the Trial Master File in a state of inspection readiness.
    • Prepare and maintain weekly internal tracking for reporting and status.
    • Other duties as assigned.
Requirements
    • B.S. degree
    • 3+ years of CRA experience monitoring clinical trials in biotech, pharmaceutical, or CRO environment.
    • Experience with outsourced clinical trials and trial conduct from start-up through close out.
    • Working knowledge of relevant ICH GCP and FDA regulations
    • Ability to work effectively with minimal supervision.
    • Ability to multi-task and manage deliverables across all assigned trials.
    • Strong written and verbal communication skills
    • Ability to travel approximately 25%.
    • Self-motivated and able to work in a small team environment.


The salary range for candidates residing in California for this position is $125,000 USD to $155,000 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 geographic location, 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.

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets