Medical Monitor – US Board-Certified Psychiatrist

PSI CRO AG

Medical Monitor overseeing psychiatric safety and clinical-trial medical guidance for PSI, a global contract research organization. Reviewing safety data, supporting regulatory work, and advising trial teams.

Posted 8/10/2026full-timeRemote • 🇺🇸 United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive medical expertise as a Medical Doctor with US Board Certification in Psychiatry, alongside a strong background in clinical research and trial management. Proficient in monitoring trial participant safety and providing regulatory input while effectively communicating and training trial teams.

Highest-signal resume keywords

Medical Doctor DegreeUS Board Certification In PsychiatryClinical Research ExperienceTrial Participant Safety MonitoringMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical MonitoringRegulatory Authority ResponsesProtocol Deviation ReviewClinical Study Report ReviewData Management SupportMedical ReviewSafety Report ReviewTrial Risk ManagementParticipant RecruitmentFeasibility Assessment

Soft Skills

Communication SkillsPresentation SkillsAnalytical SkillsProblem-SolvingTeam-Oriented

Certifications & Qualifications

US Board Certification In Psychiatry

Industry Keywords

Clinical TrialsPharmacovigilanceIRB/IECIND/SUSAR Safety ReportsIDMC CommitteesAdjudication CommitteesTrial AuditsTherapeutic Area ExpertiseTrial-Specific Medical DocumentsSafety Narratives

About the role

Key responsibilities & impact

Act as the primary point of contact for trial-specific medical and safety-related questions
Provide input for responses to regulatory authorities and IRBs/IECs
Monitor trial participant safety
Participate in participant recruitment and retention activities
Present medical matters at kick-off and investigator meetings
Train trial teams on the therapeutic area and protocol medical aspects
Develop and review trial-specific medical-monitoring documents
Manage ongoing trial risks related to medical monitoring
Perform ongoing medical review of operational clinical trial databases
Support Medical Reviewers, Pharmacovigilance, Medical Data Review, and Data Management
Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR Safety Reports, and annual IND reports
Participate in trial-related committees, including IDMC and adjudication committees
Review clinical study reports, including safety narratives and TFLs
Provide medical expertise on an as-needed basis
Prepare for and participate in trial audits and follow up on findings
Participate in feasibility assessments of potential and ongoing trials
Participate in bid defense meetings and client interactions
Act as a medical expert and provide therapeutic expertise to other PSI departments

Requirements

What you’ll need

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

Benefits

Comp & perks

Remote work / home-based in the United States
Opportunity to build a career on the frontline of medical science
Use medical knowledge and expertise to help bring new medications to patients