Stem Cell and Gene Therapy Clinical Research Manager
The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in the Pediatric Division of Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, seeks a Clinical Research Manager (CRM) to provide management and oversight of multiple clinical research projects and staff in cell and gene therapy. Reporting to the Clinical Trial Program Director, this person will manage all day-to-day activities of assigned clinical research and ensure compliance with all applicable regulatory requirements, study protocols, contractual specifications and GCP. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
The mission of the SCGT-CTO is to translate basic discoveries into innovative therapeutics to treat children with debilitating diseases for which there are no cures at present and the identification of curative therapies for such children will offer them new hope for health, improvement in their quality of life, and a reduction in medical costs compared to their present palliative, but not curative therapies.
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify 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.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, 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; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
- Assist with analysis of data and preparation of manuscripts and scientific presentations.
* - Other duties may also be assigned
- Early Phase, biologics and/or stem cell clinical trial experience strongly preferred.
- Previous supervisory experience preferred.
- Strong organizational and project management skills desired.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent 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.
- Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious disease and infections.
- May require extended or unusual work hours based on research requirements and business needs.
- Schedule: Full-time
- Job Code: 4926
- Employee Status: Regular
- Grade: J
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 86403