Medical Monitor

ROLE RESPONSIBILITIES

• Serving as a clinical team member assigned to data review for clinicians, including:
  • Verification of subject eligibility based on medical history.
  • Critical application of protocol-defined study requirements to assess data relevant to study endpoints (e.g., safety, tolerability, immunogenicity, efficacy).
  • Reviewing serious and non-serious adverse events (AEs), including:
    • Drafting and responding to site queries.
    • Ensuring accurate and timely reconciliation of safety data.
    • Reviewing reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol-specified safety surveillance and monitoring.
  • Assisting the lead clinician with:
    • Aggregate data review and interpretation.
    • Preparation and management of safety narratives.
    • Slide development for internal and external presentations.
    • Oversight or Participant in safety narrative authoring workflows.
  • Supporting additional study-related tasks as required, such as:
    • Literature reviews.
    • Data cleaning.
    • Review of training materials.
    • Participating in safety surveillance meetings and contributing to PowerPoint creation as needed.
  • Being available during normal business hours for the assigned region and working the specified number of hours per week.
  • Additional responsibilities may be added based on prior experience, including study startup or conduct activities such as eDiary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow up or protocol compliance and/or training.

Note:

There is no interaction with regulatory authorities or direct contact with site staff in this role.

• Medical degree (MD, DO, MBBS, or equivalent) required.
• Preferred:
  At least 2 years of direct patient care experience post-residency.
• Comfortable with complex medical reviews involving pediatric, adult, and obstetrical populations
• Required:
  
  Prior experience as a medical monitor, including:
  • Safety data review (non-serious and serious AEs).
  • Experience on an interventional clinical trial within the past 3 years (Vaccine trials preferred but not required).
  • Familiarity with EDC platforms (Red Cap preferred).
  • Strong ability to critically evaluate medical/scientific information.
  • Understanding of clinical study design, development, and execution.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Fluency in English (written and spoken).
  • Ability to adapt to a fast-paced and evolving environment.
  • Training and experience in infectious diseases and/or infection control in a hospital setting is preferred. Other relevant specialty experiences include:
    Family Medicine, Internal Medicine, Obstetrics and Gynecology, or Pediatrics.