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Clinical Operations Assistant

2 months ago

Petaling Jaya, Malaysia Parexel Full time

• 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.

• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)

• Photocopy, print distribute and retrieval of documents, as needed

• Maintain basic quality check procedures to ensure accurate maintenance of documents

• Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)

• Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance

• Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)

• Payment/invoice processing including internal follow up with payment specialists in Finance

• Courier shipment of study document to the sites, vendor and clients

• Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel

• Assumes the ability to meet the requirements of a COA with a high degree of proficiency

• Effective time management in order to meet daily metrics or team objectives

• Able to work independently but seek guidance when necessary, escalating issues as required