Principal Investigator Clinical Trials PT (Psych)

We are looking for a psychiatrist to serve as a Principal Investigator on a Part-time basis, M-F. You will ensure adherence to protocol requirements, protect the rights and welfare of study subjects, and assure the integrity of data generated at the site. In executing these position responsibilities, you will be guided by and promotes adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

The ideal candidate will be a Family Medicine or Internal Medicine Physician.

Responsibilities:

Employee Mentoring Responsibilities:

• Work with the Site Director and Medical Director to provide oversight of the Sub-Investigator. Reviews work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements.

Protocol Planning and Oversight:

• Work with the Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment.
• Work with the 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 ensures 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 explains 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.

Skills and Qualifications:

Education and Experience:

• M.D., D.O. required.

Requirements:

• 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 behaviour to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Experienced negotiation skills.
• Formal presentation skills.
• Excellent persuasive/selling skills.
• Understands 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 (such as Study Manager).