CRA2 - Senior CRA, single sponsor team

<p>We are recruiting for our <b>sponsor-dedicated</b> business in <b>Poland</b> and are currently seeking to hire <b>CRAII</b> or <b>Senior CRA I or Senior CRA II </b>with a <b>permanent</b> and <b>full-time contract</b>. In this role, you will be dedicated to a <b>single sponsor</b>.</p><p>Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.</p><p></p><p><b>Responsibilities include but are not limited to:</b></p><ul><li>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</li><li>Responsible for all aspects of site management as prescribed in the project plan</li><li>Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review</li><li>Monitor data for missing or implausible data</li><li>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</li><li>Ensure audit readiness at the site level</li><li>Prepare accurate and timely trip reports</li><li>Responsible for all aspects of registry management as prescribed in the project plans</li><li>Undertake feasibility work when requested</li><li>Participate in and follow up on Quality Control Visits (QC) when requested</li><li>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</li><li>Might be requested to work in a client facing environment</li><li>Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE</li><li>Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>Assist with training, of new employees, e.g. co-monitoring</li><li>Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned</li></ul><p></p><p><b>Education and Qualifications: </b></p><p>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. </p><p>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.</p><ul><li>Minimum 3.5 years of independent monitoring experience in international Pharma/CRO company</li><li>Experience in Oncology preferred but not a must; although you should be willing to work on Oncology studies</li><li>Experience in interventional studies</li><li>Excellent understanding of Serious Adverse Event (SAE) reporting</li><li>Fluent in English and Polish</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" rel="noopener noreferrer" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>