Join to apply for the Clinical Research Coordinator 2 role at Stanford University School of Medicine 3 days ago Be among the first 25 applicants Join to apply for the Clinical Research Coordinator 2 role at Stanford University School of Medicine Get AI-powered advice on this job and more exclusive features. The Department of Orthopaedic Surgery is seeking a Clinical Research Coordinator 2 (CRC2) to conduct clinical research and manage the clinical research studies with Trauma Services which specializes in orthopaedic trauma surgery, and treating all aspects of fractures of the upper extremity (except the hand), lower extremity, and pelvis, as well as nonunions and malunions. This position independently assigns trial workload and manages performance through coaching and supervision of Clinical Research Coordinator Associate, Med. Students, Med scholars, Residents, Fellows and Post-docs. The CRC2 for Trauma reports to the Chief of Orthopaedic Trauma and serves as the resourcing lead and supervisor to assure project needs are adequately met and assigns adequate coverage for workload trials. The desired candidate is detail-oriented and conscientious, with excellent written and oral communication and interpersonal skills. To learn more about the department please visit us at: Duties include*: Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. 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. Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. - Other duties may also be assigned. Education & Experience (required) Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. Knowledge, Skills And Abilities (required) Strong interpersonal skills. Proficiency with 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. Certifications & Licenses Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. Must possess and maintain a valid California non-commercial Class C Driver’s License.
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