What are the responsibilities and job description for the Medical Monitor position at System One?
Remote Medical Monitor
The Medical Monitor will serve as the physician to physician contact for an Investigator site and provide medical expertise for answering questions and resolving study related issues. The Medical Monitor will need to perform AE reviews and assist other Site Management staff with medical issues/questions and local regulatory interaction.
- 100% remote
- Reporting to NYC office
- Advise study team on risk mitigation planning
- Medical safety at trial site patient level
- SSRP (safety statistics reporting program) reporting
- Follow SOP data review guide
- Monitor safety issues and provide content to SAE reports; medical history to SAP/AP into appropriate medical context, provide clinical input to study team
- Contribute to CRO vendor selection
- Ensure data integrity of study plans
- Safety efficacy experience via medical review including delivery of topline reports and study reports in conjunction with medical writers to ensure accuracy in addition to timely reporting
- Medical degree (US certification) with documented work experience / knowledge of statistics training in infectious disease or infection in hospital environment
- Experience with investigational clinical trials
- NO pharma industry experience required.
- Licensed to prescribe medication for at least one year post internship, independent of supervision, and has utilized a license to prescribe meds in a patient care setting (aggregate/combined duration of at least one year)
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