Data Entry Specialist
hace 8 días
Secaucus
Job Description Title: Data Entry Specialist Location: Secaucus, NJ Status: Per-diem Reports To: Manager, Clinical Operations Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: The Data Entry Specialist is responsible for the accurate and timely entry of clinical trial data into electronic data capture (EDC) systems in compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This role supports the clinical research team by ensuring data integrity, completeness, and readiness for monitoring, audits, and data analysis. Responsibilities: • Accurately enter clinical trial data from source documents into EDC systems in a timely manner., • Assist with data review for completeness, consistency, and accuracy prior to submission., • Assist with resolving data queries generated by sponsors, monitors, or data management teams., • Maintain organized and up-to-date study records, including source documentation and tracking logs., • Collaborate with Clinical Research Coordinators (CRCs), investigators, and other site staff to clarify data discrepancies., • Ensure compliance with study protocols, SOPs, and regulatory requirements (e.g., FDA, ICH-GCP)., • May assist with data cleaning activities and preparation for database lock., • Track data entry progress and provide regular updates to management., • Support audits and monitoring visits by providing requested data and documentation., • High school diploma or equivalent required; Associate’s or Bachelor’s degree in life sciences, healthcare, or related field preferred., • Previous experience in data entry, preferably in clinical research or healthcare setting., • Familiarity with EDC systems (e.g., Medidata Rave, Oracle, or similar) is preferred., • Knowledge of clinical research processes and GCP guidelines is a plus., • Strong attention to detail and high level of accuracy., • Excellent organizational and time management skills., • Proficient in Microsoft Office (Excel, Word, Outlook)., • Ability to manage multiple tasks and meet tight deadlines. Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance
