Principal Investigator - Psychiatry

An excellent company is expanding and adding a Principal Investigator to their team. There is an option for INPATIENT and OUTPATIENT.

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.

DUTIES & 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 ECG’s.
• 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 sponsor’s 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.
• Ensure compliance with legal issues including but not limited to patient confidentiality and risk management; ensures compliance with federal, state and local regulations.
• Exhibit a high degree of courtesy, tact, and poise when interacting with patients, families, and other research staff and healthcare professionals.
• Collaborate with operational and management team to ensure site goals are met.
• Attend Investigator Meetings and educational seminars.
• Travel to Investigators meetings as needed.
• Provide on call outpatient and / or inpatient coverage to subjects enrolled in clinical studies.

Skills / Qualifications :

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

If this sounds like the type of opportunity you see yourself transitioning into next, contact Julie Gross at 605-705-6836.

Resumes may be sent confidentially to [email protected] .

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

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