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Clinical Research Project Manager

Palo Alto, CA

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The successful applicant will have the ability to supervise multiple clinical research staff and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.Duties include: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 assignedEnroll and follow participants in clinical trials, including scheduling and performing research evaluationsKNOWLEDGE, 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.Reference number: 59666

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