Clinical Research Coordinator
The Brain Stimulation Lab (BSL), within the Department of Psychiatry and Behavioral Sciences, is seeking an experienced Clinical Research Coordinator 2 to oversee a large clinical trial involving the use of repetitive Transcranial Magnetic Stimulation. The BSL has been at the forefront of using brain stimulation techniques to treat and study neuropsychiatric disorders. We focus on utilizing neurostimulation to probe the neural elements involved in control of conflict regulation within the human brain. The mission of the BSL is to utilize cutting-edge neuroimaging techniques in an effort to develop new hypotheses regarding proposed dysfunction within the neural networks involved in neuropsychiatric diseases/disorders.
The BSL offers research study treatments for numerous neuropsychiatric diseases/disorders. Currently, the BSL has several active studies examining topics such as treatment-resistant depression, chronic pain, suicide, and obsessive-compulsive disorder. BSL studies utilize novel brain stimulation techniques, novel psychopharmacological approaches and neuroimaging methods.
- Oversee rTMS protocol methodology execution and maintain quality and consistency of methodology as established by PI.
- Maintain current study protocols and optimize communication strategies involved in these protocols.
- 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 Device Exemption applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
* - Other duties may also be assigned
- Master’s degree which conveys a clinical license such as an MSW, MFT
- Master’s in clinical psychology.
- Experience communicating with and submitting applications to the FDA
- Experience with communications with the IRB
- Experience running a large NIH grant.
- 5 years of clinical trials experience
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.
- 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.
*- 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.