Job Description

The Senior Clinical Research Associate – SPS (Stiff Person Syndrome) is a seasoned professional with wide-ranging study and site management experience and a thorough understanding of GCP and ICH principles. The Sr. CRA will be assigned as the primary point of contact for several sites in collaborative partnership with the CRO (Clinical Research Organization) to successfully execute Kyverna’ s clinical trials across all therapeutic areas. The Sr. CRA will support and foster professional, strong, and productive relationships, placing our company as a partner of choice among sites. Strategically supports initiatives with a solution-oriented focus to overcome challenges with sites. The Sr. CRA must be self-motivated, independent, and able to work in a small team environment. The successful candidate will be a highly organized individual who can multitask and adjust direction based on changing projects and priorities. The Sr. CRA is efficient at overseeing clinical trial management activities, tracking the progress of assigned sites and identifying and resolving challenges to achieve target objectives. Effectively communicates with sites on issues related to regulatory documentation, financial payments, and upcoming studies. The Sr. CRA will be a key member of the Clinical Operations team. 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 Rigor, Elevate Each Other, and Stay True To Why.

Responsibilities:

• Partner efficiently, effectively, and professionally with participating study sites to ensure effective and compliant study conduct
• Gain knowledge of assigned institution/organization operational structure
• Work with the Sr. Clinical Trial Manager/Study Lead to implement strategic operational activities to ensure efficient study enrollment and high-quality study conduct at assigned clinical sites. The assigned clinical trial may be of high complexity
• Participate in RFP and vendor selection process, working closely with Clinical Operations leadership
• Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with CRO
• Oversee patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions
• Provide oversight of the CRO related to study start up, interim monitoring, and close-out visits, as needed.
• Proactively support feasibility, pre-study and site initiation activities and remediation, as appropriate
• Support diversity and inclusion activities in conjunction with relevant vendors
• Conduct internal and external meetings for assigned clinical trial(s)
• Escalate site and study issues/risks in a timely manner with strong communication skills.
• Develop and deliver study training to investigators, site staff, and internal staff on select study processes
• Participate in internal and external meetings (e.g., Investigator Meetings), conferences and events.
• Provide oversight review of ICFs, essential documents, and monitoring trip reports
• Assist in the development and/or review of study/program plans (i.e.., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
• Liaise with the CRO and study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
• Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
• Manage external vendors with oversight of activities
• Oversee implementation and maintenance of Trial Master File for inspection readiness.
• Provide study status updates and reports to senior management
• Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
• Develop SOPs and best practices and facilitate their implementation, as needed

Requirements:

• B.S. degree with minimum 5 years of lead CRA experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment
• Strong clinical study conduct experience from start-up through close-out
• Experience with Outsourced Clinical Trials required
• Working knowledge of relevant ICH GCP and FDA regulations
• Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
• Strong written and verbal communication ability
• Experience with Outsourced Clinical Trials required
• Ability to travel approximately 25% required

Preferred Requirements:

• Phase I/II global experience preferable
• Autoimmune or cellular therapy experience highly preferred

The salary range for candidates residing in California for this position is $100,000 USD to $110,000 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.

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