Data Entry Coordinator

The Role

• Responsible for the following data entry associated tasks for their assigned studies: source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving
• To comply & adhere to GCP guidelines and regulations as required of this role.
• To provide support to the Clinic and PM teams 

Main Tasks and Responsibilities

• Prepares study binders for source document storage as instructed by Project Management 
• Supports and performs QC of all source documents, 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 
• Performs timely lab result tracking 
• Responsible for the accurate and timely filing of all study-related documents 
• 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

The job may involve the following:

• Very high concentration of work 
• Strict and tight deadlines 
• Having to juggle a range of tasks/issues simultaneously 
• Working in a hazardous environment with high requirement to follow safety procedures 
• Working outside normal working hours 
• Needing to respond to client demands

The Candidate

• Effective communication skills
• Computer proficiency (Microsoft Word, Excel and Office Suite products)
• High School Diploma or equivalent
• 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 
  
  

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