Principal Investigator

Principal Investigator - Psychiatry Trials

Monday-Friday 8am-5pm

Staten Island, NY

Overview

The 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 Care

• Oversee all trial-related medical decisions, or make sure a qualified sub-I is covering
• Obtain signed, dated informed consent before any study procedures begin
• Make sure consent forms include every regulator-required element, and keep subjects informed of new study information
• Monitor each subject's therapy response, adherence, and adverse events per protocol
• Arrange care for adverse events and intercurrent illness, and notify the subject's primary physician of trial participation
• Report serious adverse events to the sponsor and IRB right away

Protocol Compliance

• Know each protocol thoroughly and attend sponsor investigator meetings
• Confirm inclusion/exclusion criteria fit the study population, and review visit schedules and endpoints with the team
• Follow randomization procedures
• No deviations or changes without sponsor agreement and prior IRB approval, except to eliminate immediate hazards to subjects
• Set realistic enrollment goals and assess feasibility with the Site Director

IRB Oversight

• Submit 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 changes
• Send ongoing documents (amendments, deviations, adverse events, new information) and annual status summaries, or sooner on request

Data Integrity and Documentation

• Keep case report forms accurate, complete, legible, timely, and consistent with source documents
• Explain discrepancies and sign off on corrections following written procedures
• Document deviations, premature unblinding, withdrawal reasons, and adverse events
• Retain trial records securely for the required period and provide reports to the sponsor, IRB, and regulators on request

Investigational Product

• Stay current on the IB and product information
• Take responsibility for product use and storage at the site, delegating to research pharmacy staff alongside the Site Director
• Confirm subjects use the product correctly

Team Oversight and Delegation

• Supervise the sub-investigator with the Site Director and Medical Director, checking work against SOPs, ICH GCP, and protocol
• Confirm staff are trained, have adequate resources, and understand their delegated duties
• Keep a current delegation log
• Make sure the site has enough qualified staff and facilities, and that you have enough time for the study
• Meet regularly with the research team on enrollment and study progress
• Work with the Study Coordinator and Recruitment Manager on enrollment strategies

Qualifications

• MD or DO, Licensed in New York State
• Experience working with psychiatry/CNS clinical trials
• Able 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.