USA - Exception - Clinical-Scientific - USD

Job Title: Medical Monitor - Clinical-Scientific 
Location: Fully Remote
Pay Rate: $99/hour
Duration: 1 Year

Job Description

The Medical Monitor Contractor will support clinical trial medical oversight, safety surveillance, and clinical data review to ensure subject eligibility, protocol compliance, and data integrity.

Responsibilities:

• Review subject eligibility based on medical history and protocol-defined inclusion/exclusion criteria.
• Assess clinical trial data related to safety, tolerability, immunogenicity, and efficacy endpoints.
• Review serious and non-serious adverse events (SAEs/AEs) and draft/respond to clinical data queries.
• Reconcile safety data and review reactogenicity data in eDiaries and Electronic Data Capture (EDC) systems.
• Support aggregate safety data review, interpretation, and safety narrative preparation and management.
• Assist with safety narrative authoring workflows and develop clinical safety presentations.
• Perform clinical data cleaning, literature reviews, and review of study training materials.
• Participate in safety surveillance meetings and support clinical study startup and conduct activities, as applicable.
• Support eDiary design, feasibility assessments, informed consent reviews, protocol reviews, and safety follow-up activities, based on experience.
• No regulatory authority interaction or direct site staff contact.

Education

• Medical degree (MD, DO, MBBS, or equivalent) required.

Required Skills

• Prior experience as a Medical Monitor.
• Serious and non-serious adverse event (SAE/AE) review and safety data reconciliation.
• Interventional clinical trial experience within the past 3 years.
• Clinical data review and protocol-based subject eligibility assessment.
• Clinical endpoint assessment: safety, tolerability, immunogenicity, and efficacy.
• Electronic Data Capture (EDC) systems and eDiary safety data review.
• Clinical study design, development, and execution.
• Microsoft Excel, Word, and PowerPoint.
• English fluency (written and spoken).

Preferred Skills

• Minimum 2 years of direct patient care experience post-residency.
• Vaccine clinical trial experience.
• REDCap experience.
• Infectious diseases or hospital infection control experience.
• Family Medicine, Internal Medicine, Obstetrics and Gynecology, or Pediatrics.
• Experience with pediatric, adult, and obstetrical medical reviews.
• Safety narrative authoring, aggregate safety data interpretation, and clinical safety presentations.
• Clinical study startup and conduct experience, including eDiary design, feasibility, informed consent review, protocol review, and site safety follow-up.