Construction Project Coordinator
Gray
Clinical Trials Project Manager
Rochester Regional Health
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $80,000 - $105,000 per year
Job Level
Junior
Tech Stack
Google Cloud Platform
About the role
- Liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial.
- After training, manage from 10 to 25 protocols, with contract value over $3,000,000 and >120 PM billable hours/month.
- Review clinical protocols and assist with protocol set-up functions as required.
- Develops Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
- Participate in quality audits and inspections per regulatory agencies.
- Evaluate and communicate monthly project metrics, including budget review.
- Conduct investigator training sessions by telephone or at investigator meetings, which involves overnight travel, frequently on weekend days.
- Travel to client events and ACM international locations as needed, requiring overnight travel.
- Assume responsibility for study conduct and on-call duties; ensure client’s goals and timelines.
- Maintain regulatory required study documentation and comply with standard procedures for collecting, maintaining and archiving materials.
- Develops protocol specific procedures as needed; knowledge of FDA, NYSDOH, GCP, ICH.
Requirements
- 1+ years project management experience
- Bachelor’s Degree
- Experience working in a clinical trial, laboratory or healthcare setting
- Excellent problem solving and communication skills
