We are currently recruiting for our multisponsor team in Central or Southern Poland and are looking to hire a permanent, full-time CRA II.
Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.
Responsibilities include but are not limited to:
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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; liaise with vendors; and other duties, as assigned
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Responsible for all aspects of site management as prescribed in the project plan
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Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
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Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
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Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
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Monitor data for missing or implausible data
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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
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Ensure audit readiness at the site level
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Prepare accurate and timely trip reports
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Responsible for all aspects of registry management as prescribed in the project plans
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Undertake feasibility work when requested
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Participate in and follow up on Quality Control Visits (QC) when requested
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Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
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Might be requested to work in a client facing environment
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Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
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Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
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Assist with training, of new employees, e.g. co-monitoring
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Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Education and Qualifications:
We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.
Nice to have
If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.
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Minimum 1,5 years of independent monitoring experience in international Pharma/CRO company
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Experience in Oncology preferred but not a must; although you should be willing to work on Oncology studies
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Experience in interventional studies
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Excellent understanding of Serious Adverse Event (SAE) reporting
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Fluent in English and Polish
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