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
