Stanford University School of Medicine · 2 hours ago
Research Program Coordinator in Precision Psychiatry
Stanford, CA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $97K/yr
5+ years expStanford University School of Medicine is focused on developing precision medicine approaches for mental health. They are seeking a motivated Research Program Coordinator to oversee and support clinical precision mental health studies, manage research staff, and ensure compliance with regulations.
EducationHigher EducationMedical
Responsibilities
Oversee, guide, and mentor the conduct of precision medicine in mental health research for the Center for Precision Mental Health group focused on depression and related conditions, and any other assigned clinical research group within the center
Hire, orient, train, and conduct performance reviews for staff handling research coordination activities associated with the conducting of clinical trials. These activities include oversight for functional neuroimaging scans and behavioral assessments that are essential to precision medicine trials, and which go beyond traditional efficacy or effectiveness trials
Assist with the approval and monitoring of staff timecards. Manage vacation, sick time, and leave requests, and coordinate coverage planning across research programs. Monitor in-office schedules and compliance with onsite work expectations
Managing research coordinator staffing allocations and being accountable for efficient workflows and streamlined operational procedures, identifying and implementing adequate coverage for trial workload across teams of study coordinators
Managing the systems for allocating, scheduling and communicating the activities for the different types of personnel required to implement the trials: study clinicians, physicians, coordinators and postdoctoral scholars
Establish and track productivity benchmarks (e.g., enrollment targets, data collection quotas, and protocol timelines)
Implement performance improvement plans when necessary and maintain documentation for evaluations, coaching, and corrective action
Serve as the first escalation point for staff concerns, conflicts, or operational barriers
Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials
Manage the execution of studies including the development of project schedules, targets, measurements, and accountabilities in accordance with project milestones
Lead project meetings and prepare/approve minutes
Forecast staffing needs based on enrollment projections and study timelines
Dynamically reallocate staff effort based on workload surges, site performance, and trial phase transitions
Maintain role definitions and cross-training plans to ensure operational continuity
Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct
Audit operations to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes
Oversee data management for research projects
Develop and manage systems to organize, collect, report, and monitor data collection
Extract, analyze, and interpret data
Manage IRB submission, compliance with applicable regulations and audit operations, including imaging and behavioral testing protocols
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries
Be responsible for preparing and maintaining compliant study protocol documents and binders
Collaborate with principal investigators in the preparation of progress reports to NIH
Assist with preparation and coordination of NIH RPPRs, Recruitment Milestone Reports (RMRs), and related funder submissions
Maintain audit-ready documentation for sponsors and regulatory agencies
Assist with preparation of DSMB reports and safety summaries, track DSMB meetings, Board responses, and implement recommendations
Maintain version control across DSMB deliverables
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices
Develop, track and manage study budgets and research program financial status through development of detailed reports for discussion with research leaders
Develop and coordinate study databases, integrating different types of measurements and contribute to study reports
Maintain delegation of authority logs, consent document versioning, and training documentation. Track reportable events and ensure timely regulatory filing. Ensure compliance with HIPAA, GCP, and FDA regulations as applicable
Own operational readiness for trial launch and sustainment, including audit preparation, inspection readiness, and continuity planning
Establish center-wide processes for documentation, reporting, and operational accountability
Qualification
Required
Bachelor's degree in a related field and five or more years of directly relevant experience in managing clinical research programs in behavioral health that span both clinical and objective assessments
5+ years previous full-time research experience in human subject trials with treatment arms in the fields of Psychology, Cognitive Neurosciences, or cognate fields, at a post-bachelor's level or higher
Demonstrated experience and skills with coordinating and executing human subject studies applied in mental health, from initiation to close out (i.e. overseeing IRB submission, implementing protocols, developing and implementing recruitment and scheduling strategies, training junior personnel, acquiring multiple types of data, reporting recruitment milestones, coordinating project meetings, ensuring compliance, coordinating study databases, contributing to study reports, aligning project activities with study budgets, managing project meetings and interactions with investigators)
Knowledge of psychiatric neuroscience terminology
Hands-on experience with participants experiencing mental health issues and relevant interventions
Hands-on experience with observational human trials using neuroimaging, behavioral and/or physiological endpoints
Experience executing randomized controlled trial treatment studies
Experience with FDA regulatory procedures and reporting
Demonstrated experience with regulatory requirements including Institutional Review Board requirements, HIPAA, and Good Clinical Practices
Experience managing personnel
Strong interpersonal skills
Strong diplomacy skills
Proficiency with Microsoft Office and database applications (i.e. REDCap, Cloud, EPIC)
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
Minimum of five years of demonstrated managerial and program coordination experience
Demonstrated disease knowledge/study design experience of studies under purview
Preferred
Knowledge of the emerging field of neuroimaging-guided precision medicine trials in psychiatry
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
Company
Stanford University School of Medicine
Stanford University School of Medicine is the medical school of Stanford University. It is a sub-organization of Stanford University.
5001-10000 employees
H1B Sponsorship
Stanford University School of Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (551)
2024 (499)
2023 (472)
2022 (390)
2021 (336)
2020 (260)
Funding
Current Stage
Late StageTotal Funding
$10MKey Investors
American Medical Association
2023-06-21Grant
2017-07-19Grant· $10M
Leadership Team
Darius M. Moshfeghi
Chief of Retina Division: Vitreoretinal Surgery and Medical Diseases
Quinton R. Markett
Research Professional, Utz Lab, Department of Medicine, Division of Immunology & Rheumatology
Recent News
Profound Medical Inc.
2025-12-05
Company data provided by crunchbase