Medical Monitor

Job Description

Job Summary:

• The Medical Monitor Contractor will serve as a critical member of the clinical team, responsible for ensuring the integrity and quality of clinical data and supporting clinical oversight activities.

Duties and 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 e-Diaries 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.

Additional responsibilities:

• 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 e-Diary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow up or protocol compliance and/or training.

Education and Experience:

• 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 (InForm or RedCap preferred).
• Experience with J Review or a similar data review system is preferred.

Knowledge, Skills and Abilities:

• 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.