Medical Monitor

  • location: New York, NY
  • type: Contract
  • salary: $58.14 - $68.40 per hour
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job description

Medical Monitor

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!

 
location: New York, New York
job type: Contract
salary: $58.14 - 68.40 per hour
work hours: 9 to 5
education: Masters
 
responsibilities:
  • 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)
 
qualifications:
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.

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