Principal Investigator Clinical Trials PT (Psych)

Responsibilities

• Work with the Site Director and Medical Director to provide oversight of Sub-Investigator.
• Review work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements.
• Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment.
• Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies.
• Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study.
• Maintain a current, up to date curriculum vitae.
• Maintain current licensure to practice.
• Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so.
• Assess subject compliance with the test article and follow-up visits.
• Assess subject's response to therapy.
• Evaluate for adverse experiences per protocol guidelines.
• Assist with rating scales.
• Provide new information about the study or test article(s).
• Document deviations from the approved protocol.
• Document and explain premature unblinding of the investigational product(s).
• Thoroughly familiar with the use of the investigational product(s).
• Communicate effectively with subjects, research team, IRB, and sponsor.

Qualifications

• M.D., D.O. required.
• 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.
• Demonstrate the ability to initiate activity as required and make appropriate decisions within the constraints of study protocols and regulatory requirements.
• Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or subject to change.
• Experienced negotiation skills.
• Formal presentation skills.
• Excellent persuasive/selling skills.
• Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Excellent communication skills (interpersonal, written, verbal).
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry.