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Sr In-house CRA, Ukraine - FSP

Laboratory Corporation of America Holdings (Covance)

Ukraine

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: verdana,geneva; font-size: 10pt;">Covance is looking to recruit an in-house CRA to join our sponsor in Kyiv</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: verdana,geneva; font-size: 10pt;">Responsibilities : </span></p><p style="margin: 0px;"> </p><ul><li style="color: black;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Trial and site administration: </strong> </span></li><li style="color: black;"><span style="font-family: verdana,geneva; font-size: 10pt;">Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) </span></li><li style="color: black;"><span style="font-family: verdana,geneva; font-size: 10pt;">Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers</span></li><li style="color: black;"><span style="font-family: verdana,geneva; font-size: 10pt;">Clinical supply & non-clinical supply management, in collaboration with other country roles </span></li><li style="color: black;"><span style="font-family: verdana,geneva; font-size: 10pt;">Manage Labeling requirements and coordinate/sign translation change request</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Document management:</strong></span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Prepare documents and correspondence</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Collate, distribute/ship, and archive clinical documents o Assist with eTMF reconciliation</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Updating manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Regulatory & Site Start-Up responsibilities:</strong> </span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Obtain, track and update study insurance certificates</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.</span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Publish study results for GCTO and RA where required per local legislation </span></li><li style="color: black; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Budgeting, Agreement and Payments: </strong></span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Collaborate with finance/budgeting representatives for: </span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations</span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;"> Maintenance of tracking tools </span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Contract development, negotiation, approval and maintenance (e.g. CTRAs) </span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Update and maintain contract templates (in cooperation with Legal Department) </span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Payment calculation and execution (investigators, vendors, grants) </span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;">Ensure compliance with financial procedures</span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;"> Monitor and track adherence and disclosures,</span></li><li><span style="font-family: verdana,geneva; font-size: 10pt;"> Budget closeout.</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10pt;">University Degree</span></li></ul><h2>Experience:</h2><ul><li><span style="color: black; font-family: 'Calibri',sans-serif; font-size: 10pt;"><span style="font-family: verdana,geneva;">Minimum 1-2 years in Clinical Research or relevant healthcare experience</span></span></li><li><span style="color: black; font-family: 'Calibri',sans-serif; font-size: 10pt;"><span style="font-family: verdana,geneva;">Fluent English and Ukrainian</span></span></li></ul>

Job posted: 2021-07-06