Clinical Research Manager 1

About the Role

The Department of Medicine (DoM) Clinical Research Hub (CRH) at Stanford University, in collaboration with the Division of Blood and Marrow Transplant (BMT), is seeking an onsite Clinical Research Manager 1 (CRM) to provide leadership and oversight of the clinical research study portfolio for the Auto-immune Cell Therapy (ACT) program. The ACT program focuses on stem cell transplantation and cell immunotherapy, 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.

This role involves managing a diverse portfolio of observational, interventional, and registry studies—both industry-sponsored and investigator-initiated—spanning multidisciplinary therapeutic areas including BMT, Neurology, Dermatology, Nephrology, and Hematology. The CRM will establish best practices, oversee pre-award and study start-up, monitor project timelines, troubleshoot barriers (e.g., recruitment, retention), and ensure GCP compliance and participant safety.

In this key leadership role, the CRM will interface with leadership, faculty, and collaborators within the ACT program, DoM, School of Medicine (SoM), Stanford Health Care (SHC), and external partners. The position includes supervising multiple clinical research staff, handling hiring, onboarding, training, mentorship, and performance management.

Responsibilities

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with clinical trials.
• Monitor staffing levels and ensure adequate coverage for trial workload across teams of study coordinators.
• Supervise the implementation of and adherence to study protocols; educate research staff on established policies, processes, and procedures.
• Develop strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Develop consent forms for approval by the Human Subjects Panel.
• Coordinate new protocol submissions, renewals, and revisions to the Institutional Review Board (IRB) for multiple studies.
• Complete annual reports to IRB, CSTA, FDA, and other regulatory agencies; submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; lead corrective actions/processes.
• Monitor IRB submissions and respond to requests and questions.
• Provide leadership and expertise in identifying and completing research grants; oversee financial resources, create budgets, and serve as liaison between sponsors, department accounting, and Research Management Group.
• May lead or chair committees or task forces to address and resolve significant issues resulting from research activities.
• Engage in high-level outreach and networking opportunities, representing the research program to internal and external audiences.
• Analyze trends in recruitment, ensure limited competing trials, and make recommendations for trial options; track physician compliance.
• Assist with data analysis and preparation of manuscripts and scientific presentations.

Requirements

• Bachelor’s degree in a related field.
• Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, including HIPAA, FDA regulations, IRB requirements, and Good Clinical Practices (GCP).
• Knowledge of medical terminology.
• Demonstrated managerial experience.
• Demonstrated disease knowledge and study design experience relevant to the ACT program.

Skills

• Excellent interpersonal and diplomacy skills.
• Agility and flexibility in a dynamic environment.
• Compassionate participant experience.
• Outstanding leadership, communication, and ability to work independently with integrity and attention to detail.
• Proactive problem-solving and ability to manage challenges without significant oversight.

Certifications

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.

Additional Requirements

Must possess and maintain a valid California non-commercial Class C Driver's License. Ability to drive day or night and comply with California Vehicle Code and Stanford University driving requirements when conducting university business.