The Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry is seeking a Clinical Research Manager (CRM) to manage a growing research team conducting clinical trials and neurobehavioral and developmental observational studies in children ages 8-18 years. The CRM would be expected to effectively provide leadership in determining, recommending, and implementing improvements to policies/processes as well as define best practices, model professionalism, and be available as a resource to staff during research assessments.
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials and observational research using multimodal methods. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators. Assist with analysis of data and preparation of manuscripts and scientific presentations. Develop and manage systems to organize, collect, report, and monitor data collection and integrity. Extract, analyze, and interpret data Supervise and assist with the implementation of and adherence to multimodal study protocols. Educate research staff on established policies, processes, and procedures. Collaborate with principal investigator and study sponsors, monitor and report serious adverse events, resolve study queries, and contribute to writing progress reports, and submitting data for monitoring reports. 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. Analyze trends in recruitment and make recommendations for a variety of options within a trial; track physician compliance and assure there is a limited number of competing trials. 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.
* - Other duties may also be assigned
MA/MS, Doctoral or higher degree in related field Prior experience conducting semi-structured and structured clinical interviews in children (e.g. Kiddie Schedule for Affective Disorders and Schizophrenia, Children's Depression Rating Scale, Pediatric Anxiety Rating Scale, and Young Mania Rating Scale) and adults (e.g. Structured Clinical Interview for DSM) and experience with good clinical practice (GCP) guidelines. Prior experience working with and managing clinical, behavioral, and neuroimaging data in psychiatric populations is highly desirable. Experience running NIH sponsored research studies Necessary patience and ability to work with children and their families
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, 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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Position may at times require the employee to work with or be in areas where magnetic resonance imaging is conducted or where there may be hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours (including evenings and weekends) based on research requirements and business needs.
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Stanford University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.