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Amsterdam, Noord-Holland, Nederland Fortrea Voltijd

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides 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, Fortrea is transforming drug and device development for partners and patients across the globe.


We are currently looking for talented Clinical Research Associates of all levels, to join our sponsor's team in the Netherlands.


Essential Job Duties:

  • Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of prestudy and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned.
  • Responsible for aspects of registry management as prescribed in the project plans
  • General On-Site Monitoring Responsibilities:
  • Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
  • 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. On-site Routine Monitoring Visits should be a companied by an experienced co-monitor (as per training status and agreement from Line Management).
  • 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
  • Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
  • Travel, including air travel, may be required as per essential job functions.
  • Prepare accurate and timely trip reports
  • Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Fortrea or client data management systems, as assigned by management
  • Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
  • Provide coverage for clinical contact telephone lines, as required
  • Update, track and maintain study-specific trial management tools/systems
  • Generate and track drug shipments and supplies, as needed
  • Track and follow-up on serious adverse events as assigned

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 projectrelated problems and prioritize workload for self and team
  • You have previous clinical research monitoring experience (including prestudy, initiation, routine monitoring and closeout visits).
  • Fluent Dutch and English
Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

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