Clinical Research Manager 1

The Department of Medicine (DoM) Clinical Research Hub (CRH) at Stanford University is seeking an onsite Clinical Research Manager 1 (CRM) to provide leadership and oversight of the clinical research study portfolio for the Stanford Precision Metabolic Health Center (PMHC). This portfolio will include observational, interventional and registry studies that span a multidisciplinary therapeutic area including and not limited to Hepatology, Cardiology, Endocrinology, Nephrology, Primary Care, Sleep Medicine and Bariatric-Weight Management. The CRM will be responsible for establishing best practices, monitoring project timelines and progress, troubleshooting barriers including recruitment, retention and regulatory support to ensure GCP compliance and participant safety.

This position will be in a key leadership role, interfacing with leadership and collaborators within PMHC, CRH, DoM, SoM and SHC as well as external partners, sponsors and collaborators. This position will supervise multiple clinical research staff, and be responsible for their hiring, onboarding, training, mentorship, coaching and ongoing performance management. This position will be responsible for the overall oversight of the management of clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. The ideal candidate for this role must be very experienced in both regulatory and operational knowledge needed for the conduct of observational and interventional drug and device research, display agility and flexibility in a dynamic environment and have prior managerial experience. Exceptional diplomacy, interpersonal and clear communication skills, leadership, ability to work independently and without significant oversight, integrity, attention to detail, and the ability to proactively manage challenges are essential qualities desired in a successful candidate.

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver''s License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

Core Duties:

• 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.

• 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 a variety of internal and external audiences.

• Analyze trends in recruitment and ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Core Duties:

• 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.

• 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 a variety of internal and external audiences.

• Analyze trends in recruitment and ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.