The Department of Medicine (DoM) Clinical Research Hub (CRH) at Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) to perform duties related to the coordination of clinical trials and studies for the Autoimmune Cell Therapy (ACT) program. This program is a collaboration between the Division of Blood and Marrow Transplantation (BMT) and Cellular Therapy in DoM with other divisions and departments at the School of Medicine. These multi-disciplinary collaborations across many departments and divisions create a challenging and rewarding opportunity to engage in Sponsor-Investigator, industry sponsored, and federally sponsored first-in-human research.
The ACT program focuses on stem cell transplantation and cell immunotherapy. The CRC2 will work closely with multiple investigator(s) and the BMT Clinical Research Manager (CRM) in a dynamic environment, and be responsible for supporting multiple staff members, including coordinators. The CRC2 will work on multiple investigator-initiated and industry-sponsored interventional cell therapy studies to develop recruitment and retention strategies, oversee study operation and conduct, oversee regulatory compliance and financial logistics, and ensure overall progress on projects. The position will report project progress to the team and trouble-shoot barriers.
We are a large and growing team with an emphasis on quality, effective operations, and a supportive environment. Outstanding communication and organizational skills, the ability to proactively manage challenges, a strong background in interventional clinical research, experience providing compassionate participant experience, ability to work independently, show initiative, and attention to detail are qualities desired in a successful candidate. A CRC2 with great self-awareness and self-compassion, an ability to liaise with our numerous collaborators and partners with a mature and professional demeanor will be an asset to this team.
This is an onsite role.
Core Duties :
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
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Minimum Education and Experience
Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills and Abilities :
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
Knowledge of medical terminology.
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Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
