Initiation Clinical Research Associate II

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View: 135

Update day: 09-11-2025

Location: Wavre Walloon Brabant

Category: R & D IT - Software

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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Job content

The Initiation Clinical Research Associate II(iCRA II) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.Key AccountabilitiesStart-Up(from site identification through pre-initiation)
  • Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for:
  • IRB/IEC and MoH / RA submission/approval,
  • Site activation,
  • Patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS).
Skills
  • Strong problem-solving skills.
  • Able to take initiative and work independently, and to proactively seek guidance when necessary.
  • Client focused approach to work.
  • Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Fluent command of Dutch, French and English languages.
  • Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
  • Excellent time management to meet study needs, team objectives, and department goals.
Knowledge And Experience
  • Previous experience in study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology.
  • Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.
Education
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
If you are ready to join Parexel’s Journey, please apply!
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Deadline: 24-12-2025

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