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Clinical Research Associate (NL/FR/EN)

For one of our clients, a multinational bio-pharmaceutical company, we are looking for a Clinical Research Associates to join their team !

Job Description

As a Clinical Research Associate, you will plan, execute and support clinical site management activities. In this role, you will also ensure the quality and integrity of the data collected in our client's sponsored clinical trials.

Responsibilities

As Clinical Research Associate you :

  • Evaluate, initiate, monitor & close out clinical trial sites
  • Ensure site compliance and data quality
  • Respond to site-related queries and escalates issues
  • Responsible for operational site management
  • Actively contribute to department results and goals

Key Activities:

  • Develop site visit plans, conduct Clinical Site Evaluation, Initiation, Monitoring and Close Out visits and prepare visit reports for project manager review and approval
  • Build and maintain solid and long-term professional relationships with investigators and site staff
  • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
  • Assist in preparing sites for audits, review audit reports and contribute to resolving findings
  • Identify site needs and site-related issues, escalate and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
  • Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAES)
  • Verify case reports and source documentation
  • Provide input into case report forms and study-related documents as requested
  • Perform investigational product accountability and reconciliation
  • Maintain site study supplies
  • Facilitate the resolution of clinical queries to investigative staff
  • Provide input into feasibility and identify clinical investigators
  • Ensure clinical study sites are conducting the clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations

Requirements

  • Scientific degree or qualified nurse
  • Preferably Clinical Research Associate experience or in clinical trials. At least a certain working experience
  • Knowledge and experience in international standards (GCP/ICH), international (FDA, EMA) and local regulations
  • Very good knowledge of the 3 languages : Dutch, French and English
  • Able to work in a changing and innovative environment
  • Strong organizational and interpersonal skills
  • Proven expertise in effective communication, in managing multiple priorities and in computer literacy
  • Able to work very independently within your area of responsibilities
  • An eye for detail and affinity with administration, meticulous and quality-minded
  • Driver's license B
  • Existing right to work in Europe required

Benefits

  • Contract of unlimited duration
  • Balanced salary package (including a company car, fuel card, 12 additional holidays, insurances, etc)
  • Home-based (+1 or 2 site visits/week)

Vacancy number: 21711