Medical Monitor Contractor
Summary:
Client is searching for a Medical Monitor Contractor!
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.
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
Additional responsibilities may be added based on prior experience, including study startup or conducting 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
Qualifications:
Medical degree (MD, DO, MBBS, or equivalent) required.
At least 2 years of direct patient care experience post-residency preferred
Comfortable with complex medical reviews involving pediatric, adult, and obstetrical populations
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
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
Location/Shift:
This is a remote role based in Pearl River, NY; EST time zone preferred
Monday - Friday; (40 hours per week)
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