Principal Investigator

Principal Investigator - Psychiatry Trials Monday-Friday 8am-5pmStaten Island, NYOverviewThe Principal Investigator ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.Reponsibilities Subject Safety and CareOversee all trial-related medical decisions, or make sure a qualified sub-I is coveringObtain signed, dated informed consent before any study procedures beginMake sure consent forms include every regulator-required element, and keep subjects informed of new study informationMonitor each subject's therapy response, adherence, and adverse events per protocolArrange care for adverse events and intercurrent illness, and notify the subject's primary physician of trial participationReport serious adverse events to the sponsor and IRB right awayProtocol ComplianceKnow each protocol thoroughly and attend sponsor investigator meetingsConfirm inclusion/exclusion criteria fit the study population, and review visit schedules and endpoints with the teamFollow randomization proceduresNo deviations or changes without sponsor agreement and prior IRB approval, except to eliminate immediate hazards to subjectsSet realistic enrollment goals and assess feasibility with the Site DirectorIRB OversightSubmit all initial review materials (protocol, IB, consent form, recruitment ads, subject-facing documents)Get written IRB approval before starting the study or making any protocol changesSend ongoing documents (amendments, deviations, adverse events, new information) and annual status summaries, or sooner on requestData Integrity and DocumentationKeep case report forms accurate, complete, legible, timely, and consistent with source documentsExplain discrepancies and sign off on corrections following written proceduresDocument deviations, premature unblinding, withdrawal reasons, and adverse eventsRetain trial records securely for the required period and provide reports to the sponsor, IRB, and regulators on requestInvestigational ProductStay current on the IB and product informationTake responsibility for product use and storage at the site, delegating to research pharmacy staff alongside the Site DirectorConfirm subjects use the product correctlyTeam Oversight and DelegationSupervise the sub-investigator with the Site Director and Medical Director, checking work against SOPs, ICH GCP, and protocolConfirm staff are trained, have adequate resources, and understand their delegated dutiesKeep a current delegation logMake sure the site has enough qualified staff and facilities, and that you have enough time for the studyMeet regularly with the research team on enrollment and study progressWork with the Study Coordinator and Recruitment Manager on enrollment strategiesQualificationsMD or DO, Licensed in New York StateExperience working with psychiatry/CNS clinical trialsAble to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.Knowledgeable in medical terminology to communicate with physician office and laboratory staff.Skilled in working with potential sponsors to place research with the site.Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment.