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 <10%