Senior Trials Coordinator in Clinical Neuroscience
August 10, 2018
Senior Trials Coordinator in Clinical Neuroscience
Job Number: 80044
Are you an experienced clinical research coordinator interested in a new opportunity in human neuroimaging trials for mental health, with a focus on depression and anxiety and new interventions? In this position you would be managing novel trials that use neuroimaging and behavioral measures to tailor pharmacotherapy and neuromodulation interventions for individual participants. The position would be based in the PanLab for Precision Psychiatry and Translational Neuroscience within the Department of Psychiatry and Behavioral Science. Our goal is to use brain imaging and other neuroscience approaches to improve our understanding and treatment of mental health conditions such as depression and anxiety.
The Senior Trials Coordinator in Clinical Neuroscience role is especially suited to an applicant who has experience in clinical intervention trials, but also a strong drive to expand in a new area at the cutting-edge of clinical neuroscience in psychiatry. It would be expected that the Coordinator would develop and manage protocols, including protocols for pre- and post-interventions, and setting up and implementing new intervention procedures in conjunction with study MD personnel and investigators. The position would also require experience relevant to managing trial documentation and monitoring participants; for example, in one study participants could receive a ketamine infusion and would require post-infusion monitoring and documentation.
The trials are implemented here at Stanford under NIH grants and with our partner sites at the VA Palo Alto. We collaborate with clinical personnel, partners in other Stanford departments and community mental health providers and centers. The Coordinator would be working with an immediate team of several research coordinators. We are looking for a candidate who is positive, focused on solutions, good at organization - and has prior experience in neuroscience and a strong interest in improving mental health care. The PanLab values collaboration, fairness, efficiency and conscientiousness.
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 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.
* - Other duties may also be assigned DESIRED QUALIFICATIONS:
Previous full-time post-graduation clinical trial experience in human research settings relevant to mental health.
Hands-on experience with clinical research documentation and in-depth familiarity with clinical trial protocol requirements.
Experience in managing research trials and being responsible for developing and implementing protocols.
Hands-on experience with human neuroimaging and/or behavioral and or physiological (such as EEG) measures.
Substantial experience interacting directly with human participants, including in intervention settings.
A knowledge of clinical neuroscience relevant to mental health.
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. Add Here
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.
Add or subtract physical requirements based on the requirements of your specific job. (remove this statement for posting)
*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
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 disease and infections.
May require extended or unusual work hours based on research requirements and business needs.
Location: School of Medicine, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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