Medical Monitor (US Board-Certified Psychiatrist)

PSI CRO•Remote, REMOTE

14d

About The Position

PSI is hiring a part-time consultant Medical Monitor based anywhere in the United States. Medical Monitors provide medical input to global clinical studies and advise study teams and business partners, with a focus on patient safety and well-being. The role is part of PSI's international Medical Monitoring team and contributes medical expertise to clinical research and the development of new medications.

Requirements

Medical Doctor degree.
US Board Certification in psychiatry.
At least 10 years of experience as a practicing psychiatrist.
Proficiency with MS Office applications.
Communication, presentation, and analytical skills.
Problem-solving ability and a team-oriented, detail-oriented approach.
Must not require work visa sponsorship for employment now or in the future.

Nice To Haves

Clinical research experience.

Responsibilities

Act as the primary contact for trial-specific medical and safety-related questions.
Provide input for responses to regulatory authorities and Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) regarding trial-specific medical and safety-related questions.
Monitor the safety of trial participants.
Participate in trial participant recruitment and retention activities.
Present medical matters at kick-off and investigator meetings.
Train trial teams on the therapeutic area and medical aspects of the protocol.
Develop and review trial-specific documents within the scope of medical monitoring.
Manage ongoing trial risks related to medical monitoring.
Perform ongoing medical review of the operational clinical trial database and support assigned Medical Reviewers.
Review protocol deviations.
Review RAE reports; write and/or review SAE narratives; support the Pharmacovigilance team with outstanding safety queries; and interact with sponsors on site safety issues.
Review IND/SUSAR Safety Reports, updates or amendments to essential trial records, and annual IND reports with sponsor data, as requested by the sponsor.
Participate in the management of trial-related committees, such as independent data monitoring and adjudication committees, according to their trial-specific charters.
Support Pharmacovigilance, Medical Data Review, and Data Management with reconciliation of safety and operational clinical trial databases.
Review clinical study reports, including safety narratives and tables, figures, and listings (TFLs).
Provide medical expertise as needed in trials where medical monitoring is not a contract deliverable.
Prepare for and participate in trial audits and follow up on audit findings.
Participate in feasibility assessments of potential and ongoing trials in the country or region.
Participate in bid defense meetings and other client interactions.
Act as a medical expert and provide therapeutic expertise to other PSI departments.