Clinical Research Associate (CRA) (H/F)

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Clinical Research Associate (CRA) (H/F)
Date de la dernière modification : 25/07/2015

Description de l'offre
Nombre de postes demandés : 1
Catégorie de métier : Chercheur en recherche fondamentale  (5312101)
[CADRES TECHNIQUES DE PREPARATION DE LA PRODUCTION]
Secteur d'activité : Autres services personnels
Lieu(x) de travail : WAVRE
(NIVELLES [ARRONDISSEMENT])
Votre fonction :

We are looking for an experienced CRA to complete our Internal Medicine Unit.

  • Manage a clinical study: Phase I to Phase III
  • Start Up and Close out: from start to finish: pre-study visits, initiation, routine monitoring and close out visits with respect of quality standards and timelines.
  • Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in Trial Master File (eTMF) and Investigator Study File (ISF).
  • Actively participate in Local Study Team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advise Investigators and site staff in study related matters.
  • Contribute to national Investigators meetings.
  • Initiate, monitor and close study sites in compliance with Procedural Documents. Share information on patient recruitment and study site progress within Local Study Team.
  • Drive performance at the sites. Proactively identify study-related issues, solutions and escalates as appropriate.
  • Update IMPACT and other systems with data from centres as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Perform source data verification according to SDV plan.
  • Ensure data query resolution by the site.
  • Ensure accurate and timely reporting of Serious Adverse Events by the site.
  • Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and CA&A.
  • Provide the required monitoring visit reports within required timelines.
  • Work with Data Management to ensure quality of the study data.
  • Ensure compliance with teh companies Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Votre profil
Expérience(s) professionnelle(s) :
Métier : Durée : Secteur :
Chercheur en recherche fondamentale 6 mois
Formation(s) :
Etude Domaine
Master Services médicaux et paramédicaux
Master autres
Langue(s) :
Langue Niveau
Anglais Bonne connaissance
Néerlandais Bonne connaissance
Français Bonne connaissance
Description libre :

  • Onderzoeksgegevens en –resultaten bestuderen en analyseren
  • Berekeningen, metingen, experimenten en observaties uitvoeren
Resultaten controleren
  • Wetenschappelijk onderzoek en ontwikkelingen voorstellen en verklaren
  • Het verloop en de vooruitgang van wetenschappelijke experimenten en observaties leiden en controleren
  • Wetenschappelijke, technologische, technische, reglementaire, … informatie opvolgen en actualiseren
  • Rapporten, publicaties en scripties opstellen
  • A minimum of one (1) to three (3) years monitoring experience
  • Preferentially working in a full time schedule
  • Fluent in Dutch, French and English
  • Advanced knowledge of MS Office, Excel in particular
  • Strong communication skills: build up strong relationships with site staff and with the internal staff (LDL, CRA’s, CTA’s, medical advisor,…)
  • Flexible and fast adaptation to new ways of working or new projects.
  • Able to work independently
  • Able to set and manage priorities
  • Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment
  • Strong written and verbal communication skills
Votre contrat
Régime de travail : Temps plein de jour
Type : A durée indéterminée
Salaire : Attractive salary package
Contact
Nom de la personne : Mevr. Ella Sartini
E-mail :
 
Bron:
https://www.leforem.be/HotJob/servlet/JobOffs.View?id=210941