Clinical Data Coordinator

The Clinical Data Coordinator supports the Clinical Data Manager in delivery of Data Management contracted services on assigned projects. This includes responsibility for tasks and processes associated with database build, data review and closure of the database.
Essential Duties And Responsibilities
Reads and follows the Data Management Plan (DMP) for ongoing projects
Assists in development of Clinical Data Management Systems including QC or testing activities required for database finalization
Performs testing on custom reports and listings
Assists with development of supporting Data Management documentation as required, including but not limited to: CRF Completion Guidelines, Test Subject Cases and Data Entry Guidelines
May perform data entry and/or verification tasks as necessary for assigned projects
Conducts Data Management tasks for data review, including production of reports, listing, or other outputs required, authoring / issuing queries, data reconciliation and query updates
Assists the Clinical Data Manager with data review metrics and reporting
Conducts database maintenance activities, including permissions activities, end user training, andmaintenance of training records
Conducts all activities and files documentation in accordance with SOP requirements and TMF filing guidelines
Performs final Quality Control check of profiled clinical data against paper CRFs for paper studies
Perform other duties as assigned by management
Qualifications
Bachelor’s degree in a related field of study or equivalent combination of education and work experience preferred
2 years experience in clinical research preferred
Medical terminology exposure preferred
Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
Transferrable skills in a related industry role is an asset
Proficiency in Microsoft Word, Excel, and Outlook
Effective verbal and writing skills; English + local language, if relevant
Ability to travel

Work arrangement
Yes