The Principal investigator is responsible for the oversight and execution of Psychiatric clinical trials testing new medications on the behalf of the sponsor/pharmaceutical companies. The investigator promotes Good Clinical Practices (GCP) in the conduct of Clinical Investigations by ensuring the integrity of data generated at the site and directing the conduct of the clinical investigation as to the guidelines issued by State and Federal Authorities and the Sponsor. The Investigator works collaboratively with the study team and regulatory personnel to ensure welfare of study participants. The Principal Investigator oversees execution of the study protocol, delegates study related duties to site staff, as appropriate, and ensures site compliance with study protocols, study specific laboratory procedures, and standards of Good Clinical Practice.Summary of Essential Job Functions: Responsible for maintaining up-to-date curriculum vitae. Provide Sponsor and IRB with documentation of credentials as required. Maintain all required licenses to practice and execute the job as PI. Demonstrate the proper education, training, and experience to conduct the clinical investigation. Disclose conflicts of interest as described in the regulations. Review Investigators Brochure prior to performing study related activities. Evaluate and screen potential subjects based on study eligibility criteria and perform psychiatric evaluations. Perform assessments and physical examinations as a part of clinical study procedures. Provide ongoing assessments of study subjects including any potential adverse events, or serious adverse events and ensures proper reporting of such events. Provide medical management of Adverse Events and emergent events as appropriate. Evaluate and assesses laboratory reports and ECGs Follow protocol requirements including concomitant medication allowances and review inclusion/exclusion criteria. Perform clinical rounds on patients as required and documents patient care orders. Perform and review psychiatric ratings performed by raters in accordance with the clinical study protocol. Complete protocol specific training as required per sponsors vendors to obtain certification to conduct testing and rating scales for specific protocols. Conduct and document training for all delegated individuals tasked with performing any study specific activities in the study. Complete all documentation, paper and electronic, as required per protocol. Provide oversight and ensures proper delegation of duties to appropriate staff Provide and maintain updated study related documentation as required by the clinical research trial to ensure data integrity. Evaluate and report safety reports, protocol noncompliance and any other protocol specific reports. Follow requirements for FDA form 1572.
