Clinical Data Coordinator (Per-Diem)

The Role

Responsible for data entry associated tasks for assigned studies: source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving. Comply and adhere to GCP guidelines and regulations. 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

• 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