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Stanford University · 1 day ago

Sr. Clinical Research Program Manager

Stanford, CA

Full-time

Onsite

Senior Level

$140K/yr - $165K/yr

5+ years exp

Stanford University is seeking a Senior Clinical Research Manager for the Childhood Research Obesity Prevention Lab within the Department of Pediatrics. The role involves providing leadership and oversight for complex clinical research projects, managing operations, and supervising clinical research staff while ensuring regulatory compliance and quality management.

EducationHigher EducationUniversities

Growth Opportunities

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

Clinical research managementRegulatory complianceMulti-site clinical trialsClinical Practice (GCP)Health services researchProject managementDiplomacy skillsMedical terminologyDatabase applicationsEHRs proficiencyTrainingCommunicationAttention to detailInterpersonal skillsMentoring

Required

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

Ability to implement, organize and perform oversights of all aspects of complex, multi-site, multi-level clinical studies

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

Previous clinical research management 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

Previous clinical trial experience at Stanford and/or LPCH

Previous experience with health services research methods to conduct patient-centered, community-based clinical trials using quantitative, qualitative, and implementation science methods

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

Master's degree

Society of Clinical Research Associates or Association of Clinical Research Professionals certification