Trial Master Files Record Specialist
McInnis Inc.Connecticut, United States
Posted June 4, 2025
64000 - 72000 USD year
Full Time
About the Company
McInnis Inc. provides personalized recruiting and human resources services for businesses and job seekers.
Job Description
Hybrid Position - Weekly Commute to Ridgefield, CT & Work from Home. Trial Master File Records Specialist (TRS) is responsible for providing operational expertise to trial teams and overseeing the implementation of the TMF strategy for the trial.
Requirements
- 4 Year college degree with 2+ years of TMF experience and/or 5+ years of TMF experience
- Strong communication skills
- Proficiency in computer skills, with direct working experience in multiple electronic platforms
- Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices
- Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor
Benefits
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance