Stanford University School of Medicine · 2 days ago
Sr. Clinical Research Program Manager
Stanford University School of Medicine is seeking a Senior Clinical Research Program Manager for the Childhood Research Obesity Prevention Lab. The role involves overseeing complex clinical research projects, managing operations, and mentoring staff, while ensuring compliance with regulations and quality standards.
EducationHealthcareHigher EducationMedical
Responsibilities
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials in patient-centered and community-based partnerships. Monitor staffing levels and identify adequate coverage for workload across teams of study coordinators
Supervise development, implementation, and adherence in relation to study protocols and operating procedures. Educate research staff on established policies, processes, and procedures
Oversee and monitor strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee development of consent forms for approval by Human Subjects Panel for investigator-initiated multi-site clinical research trials including behavioral and social needs interventions in partnership with patients, clinical sites, and community organizations
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
Qualification
Required
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience
Excellent interpersonal skills
Excellent diplomacy skills
Proficiency in Microsoft Office and database applications, and EHRs (i.e., REDCap Cloud, EPIC)
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
Minimum of three years of demonstrated managerial experience
Demonstrated disease knowledge / study design experience of studies under purview
Preferred
Master's degree
Excellent oral and written communication skills
Exceptional attention to detail
Experience with pediatric behavioral, nutrition, and/or community-based participatory research
Experience with managing multi-site randomized clinical trials
Experience training, mentoring, and supervising others on topics related to clinical research conduct, management, and regulatory requirements
Experience auditing clinical research projects
Training and experience in project management approaches
Society of Clinical Research Associates or Association of Clinical Research Professionals certification
Company
Stanford University School of Medicine
Stanford University School of Medicine is the medical school of Stanford University. It is a sub-organization of Stanford University.
H1B Sponsorship
Stanford University School of Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (551)
2024 (499)
2023 (472)
2022 (390)
2021 (336)
2020 (260)
Funding
Current Stage
Late StageTotal Funding
$10MKey Investors
American Medical Association
2023-06-21Grant
2017-07-19Grant· $10M
Leadership Team
Recent News
Profound Medical Inc.
2025-12-05
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