Seeking ICH/GCP Quality Assurance Associate. Physical location of applicant can be any state in the US, position is remote with quarterly on-site visits to US HQ.
Bachelors Degree, preferably in a scientific discipline. Minimum of three (3) years experience conducting GCP internal process & external clinical site audits (or vendor) in a clinical research environment. Ability to travel 20% of the time, both domestic and international.
• Demonstrated knowledge and understanding of ICH guidelines, FDA and international regulations and clinical research/development processes.
• Experience and ability to create job descriptions and write/review SOPs.
• 3-5 years of GCP auditing experience.