Psicro
Medical Monitor (US Board-Certified Psychiatrist)
Remote, REMOTE, United States
Sponsorship not specifiedDetected 12 days ago
Clinical TrialsClinical ResearchPharmacovigilanceResearchCommunicationProblem SolvingMicrosoft Office
About the role
- We focus on delivering quality and on-time services across a variety of therapeutic indications.
Responsibilities
- Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
Requirements
- US Board Certification in psychiatry required
- Proficiency with MS Office applications
Nice to have
- Clinical Research experience preferred
Compensation
- Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
Benefits
- Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
- Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
- Presents on medical matters at kick-off and investigator meetings
- Trains trial team in the therapeutic area and medical aspects of the protocol
- Develops and reviews trial-specific documents within the scope of medical monitoring
- Manages ongoing trial risks related to medical monitoring
- Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
- Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
- Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
- Acts as a medical expert and provides therapeutic expertise to other PSI departments
- Medical Doctor degree required
Visa & Work Authorization
- , writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
This listing is sourced directly from Psicro's careers page and normalized into a canonical job model.