Clinical Data 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