Data Entry Coordinator

Job Description

Job Description

Clinical Research Data Entry Coordinator — Job Description

Summary

The Clinical Research Data Entry Coordinator supports clinical trials by ensuring timely, accurate, and compliant entry of study data into electronic data capture (EDC) systems. This role works closely with study coordinators, investigators, and monitors to maintain high‑quality documentation and uphold regulatory standards across all assigned studies.

Key Responsibilities

• Data Entry & Verification — Enter source data into EDC systems (e.g., Medidata Rave, REDCap, Inform) with high accuracy; perform ongoing data cleaning and query resolution.

• Source Documentation Review — Compare source documents against EDC entries to ensure consistency and completeness.

• Query Management — Respond to data queries from sponsors/CROs within required timelines; collaborate with clinical staff to obtain missing information.

• Regulatory Compliance — Maintain adherence to GCP, ICH guidelines, and site SOPs; ensure audit‑ready documentation.

• Study Support — Assist coordinators with visit documentation, data reconciliation, and tracking of study milestones.

• Data Quality Assurance — Conduct periodic data reviews, identify trends or recurring issues, and escalate concerns to study leadership.

• Communication & Collaboration — Work with investigators, coordinators, and monitors to ensure smooth data flow and timely completion of study deliverables.

• Administrative Tracking — Maintain logs for data entry progress, outstanding queries, and visit completion status.

Required Qualifications

• Education — Associate’s or Bachelor’s degree in a health‑related field (biology, public health, nursing, etc.).

• Technical Skills — Experience with EDC platforms; proficiency in Microsoft Excel and basic data management.

• Attention to Detail — Demonstrated accuracy in data‑heavy environments.

• Clinical Research Knowledge — Understanding of GCP, ICH, and basic clinical trial workflow.

• Communication Skills — Ability to collaborate with cross‑functional teams and communicate data needs clearly.

Preferred Qualifications

• Prior Clinical Research Experience — Experience in a research site, CRO, or academic research setting.

• Familiarity with Medical Terminology — Ability to interpret clinical notes and lab reports.

• Experience with Query Resolution — Proven ability to manage sponsor/CRO queries efficiently.

Core Competencies

• Accuracy & Thoroughness
  
  
• Time Management
  
  
• Confidentiality
  
  
• Problem Solving
  
  
• Process Improvement
  
  

Optional Add‑Ons (Depending on Your Use Case)

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• A resume bullet list
  
  
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