Clinical Research Coordinator 2

Job Description Stanford University is seeking a highly motivated Lead Clinical Research Coordinator (CRC2) to play a central role in development and operational management of the Aurora Research Network an innovative multi-site research consortium focused on advancing understanding and treatment of immunopsychiatric disorders, including Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and Autism Spectrum Disorder (ASD), within the Stanford Immune Behavioral Health Program. This position will work closely with Aurora Research Network leadership to help build and manage a first-of-its-kind collaborative research infrastructure connecting academic institutions, clinicians, researchers, patient advocacy organizations, and external partners dedicated to accelerating discovery in neuroimmune and immunopsychiatric disorders. The successful candidate will independently manage complex clinical research operations spanning multiple institutions and research initiatives, with responsibility for network development, study coordination, data infrastructure, regulatory oversight, scientific operations, and collaborative project management. Duties Include Lead coordination of site recruitment, onboarding, and relationship management activities across participating research institutions and external collaborators. Develop and oversee systems for multi-site clinical research data collection, database implementation, remote monitoring, data cleaning, and secure data sharing across internal and external collaborators. Manage project timelines, operational milestones, deliverables, and cross-functional activities supporting multiple concurrent network initiatives and research studies. Coordinate multidisciplinary working groups and scientific committees involving experts across psychiatry, immunology, neurology, pediatrics, and related specialties. Maintain oversight of regulatory compliance activities, including protocol documentation, Institutional Review Board submissions, Good Clinical Practice (GCP) compliance, quality assurance monitoring, and audit readiness across internal and collaborating research sites. Collaborate with principal investigators, institutional partners, and external sponsors to support study implementation, resolve operational and data-related challenges, monitor reportable study events, and contribute to research quality improvement efforts. Support development and management of research budgets, study-related financial tracking, grant deliverables, subcontract coordination, and project resource allocation across network-supported activities. Conduct literature reviews, synthesize emerging scientific evidence, and contribute to manuscript preparation, scientific dissemination activities, and grant proposal development supporting Aurora Research Network research priorities. Assist in development of standardized operational procedures, research workflows, and best practices to support long-term growth and sustainability of the Aurora Research Network. - Other duties may also be assigned This position offers a unique opportunity to contribute to the development of a groundbreaking research network while helping advance innovative science aimed at improving outcomes for children and families affected by complex neuroimmune and neuropsychiatric disorders. Hybrid or remote work agreements may be made for the right candidate. Responsibilities Core Duties: 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 documents 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. Minimum Education And Experience 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 Strong 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. Certificates And Licenses Required Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. Qualifications [REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE] Drivers License Requirements Must possess and maintain a valid California non-commercial Class C Driver's License.Ability to drive day or night.When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.