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Senior Clinical Research Associate - Sr. CRA - CRA III


Location:
Argentina
Language(s):
Only English Required
Job Ref:
594179484
Company:
PRA Health Sciences
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.


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

Qualifications:


    Read,
    • write and speak fluent English; fluent in host country language required. 2+ ye
    • ars of clinical monitoring experience required Knowl
    • edge 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
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