Cra IiScra I

Summary of Responsibilities

As a Clinical Research Associate (CRA II / Senior CRA I) you will be responsible for the endtoend management and monitoring of clinical trial sites ensuring studies are conducted in compliance with Fortrea SOPs ICHGCP guidelines and applicable regulatory requirements. You will play a key role in delivering highquality clinical research safeguarding patient safety and ensuring data integrity across all study phases.

Your responsibilities will include:

• Site Management & Monitoring

  • Independently manage investigative sites throughout the full clinical trial lifecycle from startup to closeout

  • Perform all monitoring visit types including prestudy site initiation routine monitoring and closeout visits

  • Act as the primary point of contact for sites building strong relationships and ensuring effective communication

• Patient Safety & Regulatory Compliance

  • Ensure the protection of study participants by verifying informed consent processes and protocol adherence

  • Confirm site staff are appropriately trained and qualified to conduct study procedures

  • Maintain complete accurate and auditready regulatory documentation (including eTMF and site files)

• Data Integrity & Quality Oversight

  • Perform source document review and source data verification (SDV) to ensure accuracy completeness and compliance of clinical data

  • Identify discrepancies generate and resolve queries and ensure timely data cleaning

  • Proactively identify risks deviations and quality issues implementing corrective actions as required

• Investigational Product & Study Oversight

  • Ensure proper handling storage and accountability of investigational products in accordance with protocol requirements

  • Monitor study progress against timelines and escalate risks or delays to the study team

  • Support tracking of study supplies and site readiness

• Project Delivery & Collaboration

  • Contribute to or lead (as appropriate) monitoring plans and site management strategies

  • Collaborate crossfunctionally with project teams sponsors and vendors to meet study deliverables

  • Participate in investigator meetings project calls and site training activities

• Leadership & Oversight (SCRA I scope)

  • Act as Lead CRA or take on increased project ownership as assigned

  • Provide guidance mentoring and comonitoring support to less experienced CRAs

  • Support study startup activities feasibility and site selection where applicable

• Documentation Reporting & Systems

  • Prepare accurate and timely monitoring visit reports and followup communications

  • Maintain clinical trial systems (e.g. CTMS eClinical platforms) in line with study requirements

  • Ensure compliance with performance metrics and quality standards

• Additional Responsibilities

  • Track and follow up on Serious Adverse Events (SAEs) as assigned

  • Assist with investigator/site recruitment and documentation collection

  • Deliver site training (e.g. site initiation visits) where required

  • Travel to investigative sites as needed (approximately 60%)

Required Qualifications:

• University degree in a related life sciences or health field or equivalent relevant experience.

• Solid knowledge of regulatory guidelines and clinical trial processes.

• Fluency in English and the local office language (For NL that is Dutch for BE Dutch and French).

• At least 2-4 years of independent monitoring experience (depending on level).

• Strong organization planning and problemsolving skills.

• Proficiency with standard computer applications.

• Ability to work effectively in a matrix environment.

• Valid drivers license.

What We Offer:

• Opportunities to grow your career in a global clinical research environment.

• Collaborative and inclusive culture supporting your professional development.

• Access to learning resources and global ERGs.

• Competitive benefits tailored to your local market.

If youre passionate about contributing to highquality clinical research and want to be part of a missiondriven organization we encourage you to apply and join our talented Fortrea team.

This role is for upcoming future opportunities that may arise at Fortrea.