Stanford University School of Medicine · 1 week ago

Research Program Manager

Stanford, CA

Full-time

Onsite

Mid, Senior Level

$107K/yr - $136K/yr

5+ years exp

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Responsibilities

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

Qualification

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Clinical Research ManagementRegulatory ComplianceBudget Management GCPHealth Care EconomicsHIPAA RegulationsFDA RegulationsInstitutional Review Board RequirementsProblem-SolvingLeadershipClinical Trial ExperienceCertification in Clinical ResearchClinical Data ManagementComputer ProficiencyMentoringMicrosoft Office ProficiencyDatabase ApplicationsMedical Terminology Knowledge interpersonal skills

Required

Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes.

Previous clinical research management experience.

Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

Demonstrated managerial experience.