Medical Monitor

Katalyst CRO; Cambridge (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading company in clinical research is seeking a Medical Monitor to support their Neuroscience team. This role involves overseeing the safety and protocol adherence of clinical trials, conducting medical reviews, and participating in key safety meetings. Ideal candidates will have an MD/DO and a strong background in medical monitoring within clinical development.

Qualifications

• 2+ years clinical development experience conducting medical monitoring.
• Medical Monitoring experience for later stage trials preferred.

Responsibilities

• Support the clinical development Neuroscience team with medical and safety monitoring.
• Review and assess Serious Adverse Events (SAEs).
• Provide medical review and communicate safety data to the study team.

Skills

Excellent communication

Interpersonal skills

Independence

Education

MD/DO

Job description

Responsibilities

• Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.
• Provides medical monitoring and observation of clinical trials to ensure safety and adherence to protocol.
• Coordinates, conducts, and communicates overview of safety data and significant changes to the study team.
• Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs).
• Responsible for medical monitoring of assigned studies including data reviews, queries assigned in TESLA.
• Participates in Product Safety Team meetings.
• Reviews CSRs/IBs/submissions, etc.
• Peer review draft DRC materials.
• Monitor and compile competitive intelligence (landscape) assessments/white papers and provide medical perspective/implications.
• Assesses start-up requirements for EDC to ensure studies are set up properly for medical monitoring in collaboration with the study team.
• Conducts literature reviews at the request of study teams.
  
  

Requirements:

• MD/DO with 2+ years clinical development experience conducting medical monitoring for clinical trials.
• Medical Monitoring experience (later stage trials preferred).
• Excellent communication and interpersonal skills.
• Ability to work independently.