Research Program Coordinator in Precision Psychiatry

The Stanford Center for Precision Mental Health (PMH) within the Department of Psychiatry and Behavioral Sciences is focused on developing precision medicine approaches for mental health spanning mood, anxiety and attention disorders. Our research is centered on the goal of developing new brain-based classifications that inform an understanding of the individual and subsequent treatment selection.

PMH is seeking a motivated and experienced Research Program Coordinator in Precision Psychiatry. Reporting to the Associate Director of Precision Mental Health Research Programs, the Research Program Coordinator will provide oversight, guidance, and support for the conduct of biotype-guided clinical precision mental health studies and any other assigned clinical research groups within the Center. The Research Program Coordinator will be conversant in the goals, mission and priorities of the Center, and utilize this knowledge to conduct impactful clinical research with a focus on high quality and efficiency. We are seeking candidates with excellent organizational skills, attention to details and excellent clinical research knowledge on complex projects. Knowledge of the emerging field of neuroimaging-guided precision medicine trials in psychiatry is preferred.

The Research Program Coordinator will develop, execute, and manage complex studies funded through NIH and philanthropy. The focus is on an exciting program of clinical translational precision medicine studies funded under the IMPACT-MH initiative ('Individually measured phenotypes to advance computational translation in mental health'). These studies assess cognitive and emotional functions using functional MRI, behavioral and clinical measures in a longitudinal design and in personalized treatment designs. fMRI and behavioral testing enable the assessment of distinct biotypes of major depression and related disorders, and the personalized matching of treatments to biotypes. Treatments include novel selective pharmacotherapies and therapies, as well as standard care approaches.

To be successful in this position candidates will have demonstrated experience and skills in coordinating and executing human subject studies applied in mental health, from initiation to close out. The most direct experience would be with precision medicine trials, and projects using objective measurements such as neuroimaging within treatment trial designs. The position also requires experience in managing and training study personnel and overseeing study compliance and reporting. Candidates must be eager to take on challenges with a high degree of professionalism, initiative and flexibility.

The position will be based within the Center's Personalized and Translational Neuroscience lab (PanLab) and will be fully onsite. The Research Program Coordinator will work in close collaboration with the principal investigator, study investigators and an interdisciplinary team, and manage clinical research coordinators on the studies. Members of the Center possess deep domain experience in their chosen fields and an ability to communicate across fields.

We are seeking candidates who are motivated to a pursue a career in this area and commit to the full duration of the studies and, ideally, beyond. The position comes with opportunities to participate in study outcomes and develop professionally.

Interested candidates should include in their application:

• A cover letter addressing requirements and why you are motivated to apply to this position and contribute to research in precision mental health and how your education and experience relate to the position as described above. Applicants should highlight experience managing staff, overseeing study operations. Because this role is integral to long-term program stability, candidates should also indicate their availability for a multi-year position.

• Resume or CV.

• In the cover letter or Resume/CV, please include the names of at least three referees.

The supervising PI for this position is Dr. Leanne Williams, https://profiles.stanford.edu/leanne-williams. To learn more about the Center, please visit: http://med.stanford.edu/pmhw. The position will be based within a collaborative team that values a diversity of thought and background, cooperation, fairness, efficiency, and conscientiousness.

Duties include:

• 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.

* - The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.