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 part-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 multiple programs in the Division of Neonatal and Developmental Medicine.
Oversee subject recruitment and study enrollment goals for local and multi-site research projects where Stanford is the lead site. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Oversee data management for local and multi-site research projects where Stanford is the lead site. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
Develop project schedules, targets, measurements, and accountabilities, for local and multi-site research projects where Stanford is the lead site, 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 for local and multi-site research projects where Stanford is the lead site, and respond to requests and questions.
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries for local and multi-site research projects where Stanford is the lead site.
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures for local and multi-site research projects where Stanford is the lead site. Track patient and study specific milestones, and invoice sponsors according to study contract for local and multi-site research projects where Stanford is the lead site.
Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance for local and multi-site research projects where Stanford is the lead site.
* - Other duties may also be assigned
3 years of experience in clinical research
Advanced degree in Health/Medical field
Fluent in both writing and/or speaking Spanish strongly preferred
Knowledge of how to interpret sponsor agreements strongly preferred
Strong background in clinical trials research, including protocol design; recruitment and screening of potential participants; identification and communication of adverse health effects
Must have the ability to directly coordinate clinical trials within a 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 & able to handle multiple priorities with conflicting deadlines.
This position has a need for flexible work hours, which may involve day or nighttime coverage. There is the possibility that the shifts may 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.
Strong writing/editing 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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.
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 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 based on research requirements and business needs. Additional Information
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.