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Laboratory Corporation of America Holdings (Covance)

Brussels, Belgium

<h2>Job Overview:</h2><p style="margin: 0px;">As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp Drug Development has an FSP opportunity to match your area of expertise.</p><p style="margin: 0px;"><br />Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp Drug Development studies.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">If you share our passion to help make the miracles of medicine a reality if you have been trying to start a career in clinical trials and experienced how challenging this is, then we have the right job for you.</p><p style="margin: 0px;"><br /><strong>Are you a graduate in the field of Life-sciences or a junior professional in the field and is it your burning desire to kick-start a career in Clinical Trials… NOW?</strong><br /><strong>Labcorp Drug Development is looking to hire a Clinical Trial Associate. In this position you will be fully dedicated to our sponsor and will be partially home and partially office based.</strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong>Essential Job Duties<br /></strong>Our Clinical Trial Associate jobs are the entry point to develop a long-term career in the Clinical Research.<br />In this role you will have the following responsibilities:<br />o Support to local study team (CRAs/CLM)<br /> Assistance in tracking of documents (e.g. CA, financial agreements, contact cards, diaries, insurance certificates)<br /> Assistance in preparation of submission package to ECs/HA (initial, substantial amendments, DETF, CSR) and submission to EC/CAs<br /> Circulate and distribute Investigator brochures and track accordingly<br /> Maintenance of (basic) correspondence with Global Study Team (e.g. SLM/StM), site personnel</p><p style="margin: 0px;"> Support and maintain constructive relationships with external partners (e.g.<br />investigators, study coordinators, CROs) and internal partners (e.g. RA, Legal, PV,<br />Import/Export Dept., Controlling, Finance)<br /> Logistic management of non-drug study related supplies/services<br /> Support in local study process, presentations, mailing to sites, local personnel,<br />newsletters and correspondence<br /> Assistance in preparation, support during conduct of audits and inspections of study<br />documents<br /> Perform and/or coordinate translations of study documents<br /> Initiate the order of equipment for office staff (e.g. IT-equipment, office supplies<br /> May accompany CRAs/CLMs to investigator sites<br />o Processing of invoices and tracking of study budgets<br /> Process study-related invoices, reimbursements and track payments from or to internal<br />or external service providers and enter information into tracking system, if required.<br /> Ensure that all relevant documentation of invoices and payments is filed in the TMF<br />o Organization and support of meetings (incl. TCs)<br /> Support and/or attend and follow-up of local team meetings and local investigator<br />meetings (e.g. attendee list, agenda, compilation of materials for the meeting, writing of<br />minutes, if applicable)<br /> Logistic of the attendance of site staff to the investigators' meeting: invitations, travel<br />organization, reimbursement of expenses, etc.</p><p style="margin: 0px;">o Set-up and/or maintenance of appropriate databases and tasks other IT related<br /> Maintenance of databases (e.g. CRM, Impact, SharePoint, eRoom, study web, eDiary)<br /> Update of appropriate local law or local regulatory databases<br /> Set-up of study tracking tools<br /> May function as Local Code Administrator (LCA), superuser, or data entry for IMPACT<br /> Support in different SAP-tools, computer systems<br />o Set-up, maintenance, preparation for archiving and QC checks of the TMF<br /> Set-up of TMF files (StF, CF, SSIF) and in-house filing of TMF documents in the<br />appropriate files according to the SOP and ICHGCP and other local guidelines, and<br />ongoing file maintenance during the study to support readiness for audits and<br />inspections<br /> Prepare and update specific tracking overviews (e.g. MS-Excel spreadsheet, MS-Word<br />table) on request by CRAICLM, e.g. for follow up of document collection for ECsubmission<br />assembly, overview of drug safety documentation, disclosure agreements,<br />contracts, contacts sites if necessary, etc.<br /> Preparing in-house/out-sourced TMF files for sending to respective</p><p style="margin: 0px;">GRA Archive: Study File, Country File, Sponsor Site Files and request documents from<br />other functional areas<br /> Review, tracking and completion of checklists for and send it to responsible person for<br />Final Quality<br /> Organizes archiving of Investigator Sites Files to the independent third party company,<br />in case that the investigator asks for support when site cannot keep files in a longer<br />term.<br />o Support to RHMSM, LHMSM and LM<br /> Organization of business trips<br /> Organization of (local, regional and global) meetings and trainings,<br /> Preparation of presentations<br /> Organization of mobile phones, blackberries, business cards<br /> Prepare and initiate new starter process of all new members of GCO and StM team<br />o Support in study drug related tasks<br /> Support in study drug logistic management<br /> For drugs returned to sponsor -Order packing materials for disposal (forms, containers,<br />labels), prepare and coordinate transfer of drugs to the Waste Disposal<br />Department/Location for destruction.</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">o University or college degree, or certification in a related allied health profession from an<br />appropriately accredited institution (e.g., nursing licensure).<br />o Good oral and written communication skills;<br />o Local language knowledge;<br />o If you are currently working at a pharmacy, having experience as pharmacy assistant (or comparable position), and you think this might be a suitable position for you, please contact Labcorp Drug Development as well. We are happy to discuss and discover with you if this position would be a good fit.</p><h2>Experience:</h2><p style="margin: 0px;">o Basic understanding of the clinical trial process;<br />o Preferably previous administrative experience or equivalent training/experience;</p>

Job posted: 2021-12-14

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