Association canadienne-française de l’Ontario, Conseil régional des Mille-Îles
Parexel
Publié
Janvier 8, 2019
Catégories
Type d'emploi
Duration / Durée
Permanent
How to Apply / Comment appliquer
On the company website / Sur le site web de l'entreprise
Please Specify / Veuillez spécifier (e.g. info@acfomi.org)
https://jobs.parexel.com/job/canada/bilingual-clinical-research-associate-english-and-french/877/6148813
Advertised until / Annoncé jusqu'au
February 7, 2019
Company Phone / Téléphone de la compagnie
1 781 487 9900
Company Address / Adresse de la compagnie
195 West Street Waltham, MA 02451
City / Ville
Kingston

Description

Your Key Accountabilities:

  • Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
  • Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
  • Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Function as a mentor and role model for other CRA team members
  • Manage clinical monitoring activities, including:
    • Arranging on-site visits and logistics
    • Establishment of a site recruitment plan in collaboration with site staff during QV
    • Monitoring completeness and quality of Regulatory Documentation
    • Performing site documentation verification
    • Data collection and drug accountability in accordance with ICH GCP guideline
    • Monitoring patient safety on-site and addressing any violations in a timely manner

Skills & Experience / Compétences & expérience

Your Skillset:
•Minimum 2 years of monitoring experience in clinical research
•Educated to degree level (biological science, pharmacy or other health related discipline)
•Strong working knowledge of EDC systems and IVRS
•Experience of CTMS preferred
•Competent in written and oral English and local language
•Bilingual in English and French a plus but not required

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