Clinical Psychiatrist/Research Principal Investigator (Full Time)
This role will be a combination of clinical practice, as well as running clinical trials at a well-established outpatient mental health center treating patients in an outpatient center for various mental health disease states as identified in the DSMV. As the Clinical Research Principal Investigator you will assume responsibility as the Principal Investigator for the duration of clinical trial cycle. The focus of the trials will be on Central Nervous System (CNS) studies which fit within the patient population being treated at the site.
Direct provision of outpatient psychiatric care to an adult population at Care Plus NJ.
Complete all documentation, paper and electronic, as required per protocol
Execute and manage all clinical trials, including oversight of all study personnel and any sub-investigators/subcontractors
Provide oversight and ensure proper delegation of duties to appropriate qualified staff which supports the clinical trials
Demonstrate the proper education, training and experience to conduct the clinical investigation.
Develop, manage and maintain a Clinical Research Program Budget
Identify and implement new trials which meet the organizations goals of gaining enhanced understanding of mental health needs as well as implementing advanced interventions for those in outpatient care.
Perform pre-study and ongoing physical examinations, review lab data, as applicable, to ensure patients are medically eligible to enter and/or continue in the study.
Follow requirements for FDA form 1572.
Follow the IRB-approved research plan including recruiting subjects in a fair and equitable manner. Ensure adherence to the approved inclusionary and exclusionary criteria while maintaining appropriate source documentation which demonstrates adherence.
Maintain all required records and cooperate with any request for auditing by the HRPP, sponsor, or government agency.
Comply with all requirements for identifying and reporting unanticipated problems, adverse events, deviations, and safety monitoring reports, and any other new or significant information which may impact a subject’s safety or willingness to continue in the study.
Attend Investigator Meetings and educational seminars. Maintain all required licenses to practice and execute the job as PI or Sub-I.
Board Certified M.D. or D.O. (Preferably) - Psychiatrist
Must be licensed to practice medicine in the state of New Jersey
Active Medical Licenses
Previous Experience as a Principle Investigator or sub-investigator is desirable
Certificates and Licenses:
Valid Drug Enforcement Administration (DEA) Certificate
Valid State Controlled Substance Administration (CDS) Certificate
Valid Medical License