Principal Investigator - Clinical Trials (Psychiatry)

We are seeking a board-certified psychiatrist (background in neurology secondary) to serve as a Principal Investigator on a full-time basis. The PI is responsible for ensuring adherence to study protocols, protecting the rights and welfare of participants, and maintaining data integrity at the site, in accordance with FDA regulations, Good Clinical Practice (GCP), and applicable standard operating procedures.

Responsibilities:

Team Oversight

• Collaborate with site leadership to oversee Sub-Investigators and ensure adherence to SOPs, GCP guidelines, and protocol requirements.

Study Planning and Oversight

• Work with site staff to support effective enrolment strategies.
• Help ensure staff are properly trained and following protocol procedures.
• Confirm the site has sufficient qualified personnel, facilities, and PI availability to conduct studies properly.
• Maintain an active medical licensure.
• Oversee trial-related medical decisions, or ensure a qualified designee is available to do so.
• Monitor subject compliance and treatment response; assess for adverse events per protocol.
• Support use of clinical rating scales as needed.
• Communicate relevant study updates to participants.
• Document any protocol deviations or unblinding events.
• Maintain thorough knowledge of the study drug/intervention.

Qualifications:

• M.D. or D.O. required; board certification required.
• Strong interpersonal and collaborative communication skills.
• Familiarity with medical terminology and clinical workflows.
• Experience or interest in working with study sponsors.
• Ability to make sound decisions within regulatory and protocol constraints, even amid ambiguity or changing priorities.
• Strong negotiation and presentation skills.
• Working knowledge of GCP and ICH guidelines.
• Proficiency with Word, Excel, and general clinical research software.