PRAHS

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2017-43693

2017-43693

Title 
Clinical Research Associate 3
Job Locations 
-
Colombia
Posted Date 
11/2/2017

More information about this job

Overview

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Responsibilities

  • Applies knowledge of PRA’s policies and procedures
  • Demonstrates excellent written and oral communication
  • Demonstrates excellent knowledge of ICH/GCP
  • Displays ability to manage investigative sites to facilitate trial deliverables
  • Demonstrates ability to escalate issues appropriately 
  • Conducts monitoring to confirm subject safety and data ntegrity
  • Describes and demonstrates the principals of IP accountability
  • Identifies scientific misconduct at the site level
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
  • Mentors CRAs new to the position or company
  • Serves as an observation visit leader
  • Conducts monitoring evaluation visits
  • Assists team lead in the development of trial tools or documents
  • Assists with CTM tasks
  • Participates in the development of process changes/improvements
  • Presents at client meetings/Investigator meetings
  • Provides training to trial teams

Qualifications

  • Read, write and speak fluent English; fluent in host country language required.
  • Knowledge of ICH and local regulatory authority regulations regarding drug
  • 5+ years of clinical monitoring experience required


  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required


  • Clinical research experience
  • Knowledge of ICH and local regulatory authority regulations regarding drug
  • An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
  • Experience in monitoring complex trials
  • Participation in departmental initiatives




PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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