Data Entry Coordinator

Responsibilities

• Prepares study binders for source document storage as instructed by Project Management
• Sets up and performs Quality Control (QC) of all source documents, both paper and electronic
• Identifies discrepancies in source documents and works with clinical staff for corrections or explanations
• Evaluates query responses in eSource. May reissue query as necessary
• Enters subject data from source documents into client databases in accordance with the eCRF completion guidelines/Data Management Plan and study timelines
• Resolves or escalates queries within the established timelines
• Identifies source document or EDC database issues and promptly communicates them to the Project Management team
• Enters, tracks, and performs QC for Adverse Events and Concomitant Medications
• Performs Adverse Event and Concomitant Medication Count (source vs. eCRF)
• Performs QC for 100% of completed CRF entries
• Timely lab result tracking
• Ensures that volunteer source document files/binders are ready for monitoring visits
• Provides supervisor a daily update of status for all data entry associated tasks for assigned studies
• Maintains record of entry/QC in tracker spreadsheet
• Reports protocol deviations promptly
• Archives completed study documents according to established SOPs and Work Instructions
• Accounts for unscheduled lab reports and performs QC/QA for lab data transfer files as assigned by Project Management
• Assists with all other duties as assigned
• Acts as recorder for clinical activities in eSource as required
• Supports clinical and PM staff as assigned

Job Demands

• Very high concentration of work
• Tight deadlines
• Juggling a range of tasks/issues simultaneously
• Working in a hazardous environment with high requirement to follow safety procedures
• Working outside normal working hours
• Responding to client demands

Qualifications

• Effective communication skills
• Computer proficiency (Microsoft Word, Excel and Office Suite products)
• Data input and/or QC review experience
• Able to assume increasing levels of responsibility and perform effectively
• Able to plan, coordinate, organize, and prioritize to meet deadlines
• Able to interact successfully with team members and study participants
• Self-directed - able to perform with minimal supervision
• Thorough in task completion - attention to detail
• Able to read and understand protocols