CRA II

• 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.
• 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

Learn more about our EEO & Accommodations request here.