The role of the Senior Clinical Operations Assistant (Sr. COA) is to maintain the paper and electronic
Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.
Depending on the location of the role may include the tracking, scanning, filing, entry and return of
Case Report Forms to clients for assigned projects, upload and naming of documents to the
electronic document management system, EDC User Management activities and activities associated
with Impact Harmony, as appropriate.
Sr. COA is also to support all site management team members on local billable administrative tasks
and assist with QC of Central files.
Track, scan, code, and apply naming convention and send documents to
the relevant study Work In Progress (WIP) area and Central File (CF)
area of PMED as per the Central File Maintenance Plan.
location as per the Central File Maintenance Plan (CFMP)
and study specific site trackers (Client additional request only)
obligations, Site Compliance regarding Safety Information System (SIS)
etc.) to ensure compliance
System (CTMS), Electronic Document Management System (EDMS), and MS-Office products
such as Excel and Word.
international and local regulations and applicable PAREXEL procedures and Client specific
Knowledge and Experience :