Medical Monitor - Remote

Overview

The Medical Monitor at Peachtree BioResearch Solutions provides leadership and therapeutic area medical expertise in the development of clinical research strategic programs, acting as a medical resource to support protocol development and safety management.

In Short

• Work closely with sponsors and research centers on product development.
• Participate in developing clinical strategies throughout studies.
• Assist in writing clinical protocols and CIPs.
• Review data management specifications for critical endpoint variables.
• Serve as clinical author in regulatory filings.
• Review safety data and summaries.
• Monitor incoming Safety Events and ensure proper information flow.
• Act as medical liaison between stakeholders.
• Attend Sponsor/Principal Investigator meetings.
• Develop Safety and Medical Monitoring Plan drafts.

Requirements

• M.D., D.O., or equivalent required.
• CNS / Neuroscience expertise necessary.
• Experience with complex clinical trials required.
• Training on FDA regulatory requirements and GCP/ICH guidelines.
• Ability to work independently and cooperatively with teams.

Benefits

• Medical, Dental, Vision, Life, Disability coverage.
• 20 days PTO + PTO rollover + 13 paid holidays.
• 401(k) plan.