The Stanford Center for Precision Mental Health and Wellness (PMHW) within the Department of Psychiatry and Behavioral Sciences is seeking a motivated and experienced Senior Research Coordinator in Precision Psychiatry and Neuroimaging (Clinical Research Coordinator 2) to lead the execution of precision medicine in mental health studies. The Senior Research Coordinator in Precision Psychiatry and Neuroimaging will have the opportunity to make innovative contributions to the rapidly emerging field of precision medicine in mental health.
The senior coordinator will develop, execute, and manage studies funded through NIH, including a study launching in 2024 under a priority precision medicine in mental health initiative. These studies use clinical psychiatric assessments of depression and anxiety and incorporate cognitive testing and functional magnetic resonance imaging to identify neural functional biotypes within depressive and anxiety disorders. In treatment trials, these same measures are used to enrich samples for particular biotypes, to personalize interventions and assess treatment outcomes. Intervention studies include novel selective pharmacotherapy and exploratory interventions such as MDMA.
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 projects using measurements such as neuroimaging within treatment study designs, and with treatment trial designs. The position also requires experience in managing and training study personnel and overseeing study compliance and reporting.
The position will be based within the Center’s Personalized and Translational Neuroscience lab (PanLab) and will be fully onsite. The senior 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.
Studies launched during 2024 will continue for at least five years. 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.
- 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, Dr. Leanne Williams. To learn more about the Center, please visit: Stanford PMHW. The position will be based within a collaborative team that values a diversity of thought and background, cooperation, fairness, efficiency, and conscientiousness.
For specific enquiries about the position: pmhw_admin@stanford.edu.
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.
- 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.
- 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.
- Collaborate with principal investigators in the preparation of progress reports to NIH.
- 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.
- Managing the execution of studies, including recruitment milestone reporting, coordinating project meetings, ensuring compliance, aligning project activities with study budgets, managing project meetings and interactions with investigators.
- Develop and coordinate study databases, integrating different types of measurements and contribute to study reports.
DESIRED QUALIFICATIONS:
- 1-2 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.
- 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.
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.
WORKING CONDITIONS:
- 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.
