The Department of Pediatrics, Division of Neonatal and Developmental Medicine is a dynamic and stimulating workplace focused on improving the care and outcomes of newborns. Our staff have particularly challenging and rewarding roles. We are seeking a full time (1.0 FTE) Clinical Research Coordinator 2 to support the overall management and implementation of an assigned set of research protocols in the Division.
The Clinical Research Coordinator reports to the Division Manager of Clinical Research and will assist the principal investigators (PIs) in the Division with assigned studies related to neonatology and infant/child follow-up by overseeing the day-to-day project responsibilities. The Clinical Research Coordinator functions as key liaison between study investigators, sponsors, subjects, and institutional organizations including IRB, research management group, and the contracts office. The role of the Clinical Research Coordinator is critical in ensuring that assigned studies are conducted in accordance with federal regulations/guidelines for human subjects and good clinical practice (GCP) standards. This position will support different programs in the Division of Neonatal and Developmental Medicine.
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. 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
DESIRED QUALIFICATIONS: 3 years of experience in clinical research Bachelors degree in health/medical field (e.g. Biology, Chemistry, etc.) Fluent in writing and/or speaking Spanish strongly preferred Knowledge of interpretation of sponsor agreements strongly preferred Strong background in clinical trials research, including protocol design, screening and recruitment of potential participants, identification and communication of adverse health effects Must have ability to directly coordinate clinical trials within clinical and clinical research setting, demonstrated ability to work effectively within a moderately autonomous environment in addition to having a complete commitment to achieving goals Must be flexible, dependable, and able to handle multiple priorities with conflicting deadlines The position has a need for flexible work hours which may involve day or nighttime coverage. Hours will change based on the research needs of the Division Must be able to work off-site
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. May require a valid California Drivers License. Add Here
PHYSICAL REQUIREMENTS*: 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. Add or subtract physical requirements based on the requirements of your specific job. (remove this statement for posting)
*- 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 hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious disease and infections. May require extended or unusual work hours 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.