Principal Investigator Jobs

Company Overview

Our client is a privately held network of seven research sites throughout South Florida, conducting Phase I-IV research trials with a primary emphasis on psychiatry and neurology. They are a rapidly growing pioneer of clinical and medical innovation, bringing novel therapeutics to market and changing the quality of life for millions.

In addition to conducting clinical trials, they also offer data management, bioanalytical lab analysis, medical writing, protocol design and review, project management, budget development and clinical data monitoring services through established vendor relationships and inhouse resources.

Position Summary

The Principal Investigator (Psychiatry) will be instrumental in the oversight and execution of clinical trials testing new Psychiatric therapies.

In this capacity, you will have responsibility for the overall execution of the study protocol, delegation of study related duties to site staff, and ensuring site compliance with study protocols, study-specific laboratory procedures, and standards of Good Clinical Practice. Success in this role will be driven by your ability to work collaboratively with the study team and regulatory personnel to ensure the welfare of study participants, while safeguarding the integrity of data generated and directing the conduct of the clinical investigation according to State, Federal, & Sponsor guidelines.

Primary Responsibilities

• Evaluate and assesses laboratory reports and ECG’s
• Complete all documentation, paper and electronic, as required per protocol
• Ensure compliance with legal issues, including, but not limited to, patient confidentiality and risk management; ensures compliance with federal, state and local regulations
• Evaluate and screen potential subjects based on study eligibility criteria and perform psychiatric evaluations
• Demonstrate the proper education, training, and experience to conduct the clinical investigation
• Review Investigators Brochure prior to performing study related activities
• Perform clinical rounds on patients as required and document patient care orders
• Collaborate with operational and management team to ensure site goals are met
• Provide on-call outpatient and/or inpatient coverage to subjects enrolled in clinical studies
• Provide medical management of Adverse Events and emergent events as appropriate
• Responsible for maintaining up-to-date curriculum vitae and provide Sponsor and IRB with documentation of credentials as required
• Complete protocol specific training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols
• Provide ongoing assessments of study subjects including any potential adverse events, or serious adverse events and ensures proper reporting of such events
• Provide and maintain updated study related documentation as required by the clinical research trial to ensure data integrity
• Conduct and document training for all delegated individuals tasked with performing any study specific activities in the study
• Perform and review psychiatric ratings performed by raters in accordance with the clinical study protocol
• Attend Investigator Meetings and educational seminars, and travel to Investigators meetings as needed
• Maintain all required licenses to practice and execute the job
• Evaluate and report safety reports, protocol noncompliance and any other protocol specific reports
• Provide oversight and ensures proper delegation of duties to appropriate staff
• Exhibit a high degree of courtesy, tact, and poise when interacting with patients, families, and other research staff and healthcare professionals
• Follow protocol requirements including concomitant medication allowances and review inclusion/exclusion criteria
• Perform assessments and physical examinations as a part of clinical study procedures

Core Qualifications

• 1-3 years experience conducting psychiatric clinical research trials as either a PI or Sub-investigator, or other relevant experience
• Active DEA license, or able to obtain one
• Active license to practice medicine in the state of Florida, or ability to obtain one immediately
• Board certification in psychiatry
• Possess a valid MD or DO medical degree
• Ability to read, write, and interpret the English language
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required