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location: New York, New York
job type: Contract
salary: $58.14 - 68.40 per hour
work hours: 9 to 5
- 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 often be responsible for several different studies, potentially across TAs, covering a region, and will need to perform AE reviews and assist other Site Management staff with medical issues/questions and local regulatory interaction.
- Answer medical (safety & protocol) questions directly from sites or from the Site Manager (SM)
- Serve as timely, local language physician (or English speaking physician to other countries within respective region) to physician contact
- Answer specific inclusion/exclusion criteria questions
- Provide medical expertise specific to a region
- Perform local AE review that occurs prior to the GMM review
- Review and assess causality on all SAEs on a regional level
- Follow-up with the Investigator for additional information or clarifications as needed
- Independently review large scale data listings from a clinical/medical perspective
- Post queries in EDC system and follow all queries to resolution
- Review serious adverse event narratives and compare to clinical database
- Protocol Deviation and subcategorization
- Clinical Narrative Review
- Clinical/medical review of subject data; reconciliation of data between multiple sources
- Position will report to Clinical Team (under Clinical Data Review Team)
At least 5-7 years clinical scientist/clinician/monitoring/CRA experienced required but not mandatory if strong in data review or other skills and demonstration of quick learner.
- Experience in the pharmaceutical industry in clinical development is highly desirable (3 -5 years)
- Thorough knowledge of the investigational product(s), the protocol, applicable SOPs, GCP, data privacy laws and local regulatory requirements
skills: GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.