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Clinical Research Associate

2 maanden geleden

Amsterdam, Noord-Holland, Nederland NLF Fortrea Netherlands BV Voltijd

At NLF Fortrea Netherlands BV, we are seeking a talented Clinical Research Associate to join our team in the Netherlands.

As a Clinical Research Associate, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance. You will also be responsible for aspects of registry management as prescribed in the project plans.

Key Responsibilities:

  • Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition.
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

Requirements:

  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines.
  • Minimum 1 year of direct monitoring experience.
  • Excellent understanding of Serious Adverse Event (SAE) reporting.
  • Ability to resolve project-related problems and prioritize workload for self and team.

We are a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.

We are currently looking for talented professionals to join our team in the Netherlands. If you are a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials, we encourage you to apply.