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Clinical Research Associate 2

Job Description

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.
  • 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
 

 

Specialist Experience

  • Read, write and speak fluent English; fluent in host country language required.
  • 2+ years of clinical monitoring experience required
  • Knowledge of ICH and local regulatory authority regulations regarding drug
  • 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 all trial components (PSSV to COV)
  • Experience in coaching/mentoring other CRAs

 

Please note that all information in this job description is accurate at the time of posting.  Please be aware that companies may change details and/or closing dates without notice.

 

 

Job Summary

Company
PRA
City
Sao Paolo
Country
  • Brazil
Industries
  • R&D/Science
Job Type
  • Full-time
Salary
  • Negotiable
Reference
GWP263496
Posted
11 January 2018
Applications Deadline
17 February 2018

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