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Senior Research Coordinator in Precision Psychiatry and Neuroimaging
2 months ago
We are seeking a highly motivated and experienced Senior Research Coordinator to join our team at the Stanford Center for Precision Mental Health and Wellness. As a key member of our research team, you will play a critical role in the execution of precision medicine in mental health studies.
About the Role:The Senior Research Coordinator will be responsible for overseeing subject recruitment and study enrollment goals, developing and managing systems to organize, collect, report, and monitor data collection, and collaborating with principal investigators and study sponsors to ensure regulatory compliance.
Responsibilities:- 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
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations
- 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
- 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
- Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience
- 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
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
- May require a valid California Driver's License
- 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 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
