Clinical Operations Assistant
Parexel
Bucharest, București, Romania
6 zile în urmă

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.

  • 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

    Qualifications

  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management
  • System (CTMS), Electronic Document Management System (EDMS), and MS-Office products

    such as Excel and Word.

  • Maintain a strong knowledge and ensure compliance with applicable ICH-GCP Guidelines,
  • international and local regulations and applicable PAREXEL procedures and Client specific

    procedures.

  • Good oral and written communication skills to internal and external customer
  • Ability to prioritize multiple tasks and achieve project timeline
  • High commitment to and performs consistently high quality work
  • Effective problem solving skills
  • Mentor and train less experienced staff as appropriate
  • Active participant as a process and / or platform Subject Matter Expert (SME) with minimal LM
  • oversight.

  • Good written English skills
  • Knowledge and Experience :

  • Experience in office management in an international environment would be advisable
  • Education :

  • Relevant qualification or equivalent experience required
  • High school diploma ideally degree in life science or other related background - preferred
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