Medical Monitor – US Board-Certified Psychiatrist

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the main point of contact for medical and safety-related inquiries specific to trials.

• Contribute to the formulation of responses for regulatory authorities and IRBs/IECs.

• Oversee the safety of trial participants.

• Engage in activities aimed at enhancing participant recruitment and retention.

• Present medical topics at kick-off and investigator meetings.

• Educate trial teams on the therapeutic area and medical components of protocols.

• Create and assess trial-specific medical-monitoring documents.

• Manage ongoing medical monitoring risks associated with the trial.

• Conduct continuous medical reviews of operational clinical trial databases.

• Evaluate protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and annual IND reports.

• Assist Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation.

• Take part in trial-related committees, including IDMC and adjudication committees.

• Review clinical study reports, which encompass safety narratives and TFLs.

• Offer medical and therapeutic expertise to PSI departments and trials.

• Prepare for and engage in trial audits, as well as follow up on audit outcomes.

• Participate in feasibility evaluations for potential and ongoing trials in the country/region.

• Take part in bid defense meetings and client communications.

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• US Board Certification in psychiatry is necessary.

• A minimum of 10 years of experience as a practicing psychiatrist is required.

• Clinical Research experience is preferred.

• Proficiency in MS Office applications is essential.

• Strong communication, presentation, and analytical skills are needed.

• Must possess problem-solving abilities and be team and detail-oriented.

• Must be based anywhere in the United States.

• Must not need work visa sponsorship now or in the future.

🏝️ Benefits

• Option for remote work.

• Opportunity to become part of PSI's international Medical Monitoring team.

• Career development at the forefront of medical science.

• Chance to assist in bringing new medications to patients.