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Friday, 25 April 2014

Research Operations Assistant

Research Operations Assistant 
PAREXEL International - Bangalore


Job Description :
The role of the Research Operations Assistant (ROA) is to support all site management team members on local billable administrative tasks. The ROA has a basic understanding of Clinical Operations service offerings and processes.
Key Accountabilities
  • Track, scan, code and send documents to the relevant study Work In Progress (WIP) area of PMED or send wet-ink documents to the respective Central Files office location as per the Central File Maintenance Plan (CFMP)
  • Complete the set-up, configuration and distribution of Investigator Site Files (ISF) under the supervision of the local site management team members
  • Support local site management team in the preparation of site-specific documents and cover letters
  • Copy documents or coordinate copying if done by a vendor
  • Distribute study documents to sites and/or local authorities (e.g. via courier shipments) as required
  • Assist with quality checks of submission packages (as applicable)
  • Assist with the organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
  • Check incoming faxes and escalate any urgent faxes (e.g. reported Serious Adverse Events) to CMA
  • Assist CMA with payment/invoice processing including internal follow up with payment specialists in Finance
  • Assist local site management team members with tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (if applicable)
  • Assist with the collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL
  • Assist with logistics for in-house and on-site audits.

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