Manage Data : Accurately and efficiently transcribe data from source documents to electronic data capture (EDC) systems. You'll also work with Clinical Research Coordinators (CRCs) to ensure timely and accurate data entry for multiple clinical trials.
Ensure Quality : Perform quality checks ("buddy checks") on source documents to verify data integrity.
Maintain Compliance : Uphold the strictest adherence to all best practices and regulations, including the FDA Code of Federal Regulations, ICH, and GCP. You will also assist with preparing for internal and external data audits.
Collaborate : Build and maintain strong professional relationships with various teams, including Clinical Operations, Quality, Regulatory, and external partners like CROs and Sponsors.
Data Entry • Toms River, NJ, United States