- Title: Medical Monitor
- Code: RCI-20164-1
- Posted Date: 01/12/2021
- Duration: 12 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
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)
• Answer specific inclusion/exclusion criteria questions
• Respond to safety questions from the site or local IRB/IEC
• 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
• Write country or site specific Informed Consent Forms (ICF) • May include discussions with the GMM regarding local practice of medicine vs. the study protocol
Education/Preferred Experience Required:
• Medical Degree M.D./ D.O. is mandatory
• Experience in medical practice and fully trained in all aspects of clinical trials, GCP, and evaluation of adverse events.
• Subspecialty training desirable, but not required.
• 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
• Medical background is a MUST