Telecommute Quality Study Representative

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Mar 21, 2018

Job Category: Quality Assurance

Telecommute Level: Frequently

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Education Level: Some College

Job Summary

A clinical research organization is in need of a Telecommute Quality Study Representative.

Core Responsibilities Include:

  • Providing Quality Assurance oversight for assigned studies
  • Providing support and consultancy for study related Quality Issues
  • Planning, scheduling and conducting contract study audits

Applicants must meet the following qualifications:

  • Ability to travel domestically and internationally approximately 30%
  • Four-year college curriculum with concentration in biological, physical, health, pharmacy or other related science and 4+ years of relevant GCP, GLP, GVP experience
  • Strong working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
  • Strong understanding of the Drug Development Process
  • Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES)
  • Strong understanding of clinical research principles and processes for clinical trials