Clinical Research Data Entry Specialist

Key Responsibilities

• Enter clinical trial data into Electronic Data Capture (EDC) systems accurately and within required timelines.
• Review source documents and medical records to ensure complete and accurate transcription of participant data.
• Verify data for accuracy, completeness, and consistency prior to submission.
• Review, investigate, and resolve EDC data queries generated by sponsors, contract research organizations (CROs), or data management teams by comparing source documentation and collaborating with study personnel.
• Communicate with Clinical Research Coordinators, investigators, and other study staff to resolve missing, incomplete, or inconsistent data.
• Correct data discrepancies while maintaining appropriate documentation and audit trails within the EDC system.
• Ensure timely completion of data entry and query resolution to support study milestones and database lock.
• Maintain accurate study documentation related to data entry activities.
• Adhere to study protocols, sponsor requirements, Good Clinical Practice (GCP), HIPAA, and applicable regulatory guidelines.
• Absorb and assist with quality control reviews and support sponsor monitoring visits, audits, and regulatory inspections as needed.

Qualifications

• A high school diploma or equivalent.
• 1+ years of data entry, administrative support, medical office, or related experience.
• Excellent attention to detail and data accuracy.
• Strong organizational and time management skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong written and verbal communication skills.