Sr. Clinical QA Job in Exton 19341, Pennsylvania Us
A Bio Tech company in the Exton, PA area is looking for a Sr. Clinical Research Quality Assurance associate. The candidate must have at least 5 years working as a Clinical Auditor and will be responsible for GCP audits of Phase I – III clinical research trials.
Responsibilities include:
-Extensive experience performing audits on external vendors/CRO's, Trial Master Files, study reports, investigator sites, and GCP-related systems for clinical trials conducted
-Plan, schedule, and conduct QA audits to assure adherence to company Standard Operating Procedures
-Audit clinical investigator, trial master files, system/process, document and vendor audits/assessments
-Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved.
-Monitors clinical operations
Required Skills:
GCP Auditor, QUALITY ASSURANCE, ICH/GCP, Development of SOP's
Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.