CRA or SCRA

2 weken geleden

Amsterdam, Noord-Holland, Nederland NLF Fortrea Netherlands BV 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 close-out of clinical sites, maintenance of study files, conduct of pre-study 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 project-related problems and prioritize workload for self and team You have previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits). Fluent Dutch and English

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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