Clinical Research Coordinator 2 **School of Medicine, Stanford, California, United States** **New** Research Post Date 1 day ago Requisition # 105709 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 a physician scientist in the division with the implementation and execution of multi-site clinical studies of infants in the NICU. The Clinical Research Coordinator reports to a faculty leader and will assist the principal investigator (PI) 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 a 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. **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_ _~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~_ **DESIRED QUALIFICATIONS:** · ≥2 years of experience in clinical research · Organized and detail oriented · Bachelor’s degree in health/medical field (e.g. Biology, Chemistry, etc.) or adequate experience in clinical research or the medical field · Experience implementing clinical research protocols including screening and recruitment of potential participants, identification and communication of adverse health effects, data collection and recording. · Demonstrated ability to work effectively within a moderately autonomous environment in addition to having a complete commitment to achieving goals. · Ability to independently problem solve or speak out help obtaining solutions, gathering necessary information to achieve study goals. Willingness to overcome logistical hurdles that may arise. · Good communication skills, willingness to integrate within a larger medical and research community/division. · Must be flexible, dependable, and able to handle multiple priorities with conflicting deadlines · Must be able to work on-site when needed for in-person activities (which at times will be 70-100% of work load). · Experience with REDCap or willingness to learn this data capture software. · Experience or willingness to learn IRB and other regulatory guidelines related to human subjects data collection, storage, and transmission. · Experience or willingness to learn how to work with nursing and other clinical staff to arrange for collection and storage of biological samples amd schedule/help facilitate performance of diagnostic studies and administration of study medications within a hospital setting. **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 Driver’s License. **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. + Position will be a mix of work in an office, primarily computer based work and hospital-based work liasing with the PI, clinical staff, and study participants and their family. The 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. The position will require the employee to label and transport body fluids (using appropriate safety precautions) from the medical unit to the storage laboratory. + Rarely may require extended or unusual work hours based on research requirements and business needs. *- _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. _Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. The pay range for this position working in the California Bay area is between $84,856 to $97,021 based on commensurate experience and background._ Additional Information + **Schedule: Full-time** + **Job Code: 4923** + **Employee Status: Regular** + **Grade: H** + **Department URL:** **http://pediatrics.stanford.edu/** + **Requisition ID: 105709** + **Work Arrangement : Hybrid Eligible**