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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Numbers & Facts
Location
Charlotte, NC
Skills
Academic Researchunmatched
Biologyunmatched
Clinical Dataunmatched
Clinical Laboratoryunmatched
Clinical Researchunmatched
Clinical Supportunmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Communication Skillsunmatched
Contract Research Organization (CRO)unmatched
Data Cleaningunmatched
Data Entryunmatched
Data Managementunmatched
Data Qualityunmatched
Detail Orientedunmatched
Documentationunmatched
Documentation Reviewunmatched
Electronic Data Capture (EDC)unmatched
GCP (Good Clinical Practices)unmatched
ICH Regulationsunmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Terminologyunmatched
Microsoft Excelunmatched
Nursingunmatched
Organizational Skillsunmatched
Performance Analysisunmatched
Performance Reviewsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Public Healthunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Reconciliationunmatched
Regulationsunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
Time Managementunmatched
Trend Analysisunmatched
Use Casesunmatched
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