Location: Princeton, NJ (Hybrid, 3 days on-site 2 days remote)
Contract Length: 6-12+ Months
Position Summary:
This position will be responsible for all QA oversight of GCP activities. The primary responsibilities will be to ensure quality and compliance of:
• Sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices)
• Non-clinical team on ensuring GLP studies are conducted in a compliant manner.
Responsibilities:
• Schedule, oversee and perform routine and non-routine quality assurance audits to include:
o Clinical investigator sites
o Animal testing sites
o Vendors
o Process, system, study project
o Document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines
• Provide GCP and GLP QA oversight and support internal staff.
• Assist Clinical Ops in the development of SOPs and other quality documents.
• Develop and implement detailed audit plans and yearly audit schedules.
• Ensure the timely and effective follow up of all identified or assigned quality issues
• Assist in preparing investigational sites for regulatory inspections.
• Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
• Conduct QA review of GLP reports.
• Schedule and/or execute yearly GCP training for staff.
• Assists with GCP training of study site personnel as needed.
Minimum Qualifications:
• Bachelor’s Degree in a scientific discipline. Alternatively, relevant education and job experience may be considered in absence of a Bachelor’s Degree.
• Minimum of 5 years in the Pharmaceutical industry with 2 years in GCP QA.
• Solid understanding of GCP, GLP and ICH clinical requirements.
• Experience with both domestic and international clinical studies.
• Able to travel domestically and internationally approximately 25% of the time .