Principal Investigator - Clinical Trials (Psychiatry)

Responsibilities

• Collaborate with site leadership to oversee Sub-Investigators and ensure adherence to SOPs, GCP guidelines, and protocol requirements.
• Work with site staff to support effective enrolment strategies.
• 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.