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Clinical Research Associate (CRA) I - sponsor-dedicated

Laboratory Corporation of America Holdings (Covance)

Paris, France

<h2>Job Overview:</h2><p style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Clinical Research Associate (CRA) I - sponsor-dedicated</strong></span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Location: Paris, France</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas – improving health and lives every day.</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for therapies across a wide spectrum of indications: oncology, vaccines, cardiovascular, neurology, etc. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity!</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"><strong>What you can expect from us:</strong></span></p><ul style="margin-top: 0cm;"><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">flexible working hours, capped overtime and compensatory time off in lieu</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">100% home-based, permanent employment contract with Labcorp Drug Development</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">travel time = work time</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">highly competitive compensation packages</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">subsidized meals and transportation allowances</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">bonus schemes / profit sharing</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">regular, merit-based salary adjustments</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">significant employer contribution to an attractive pension scheme</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">extensive insurance coverage, including medical, life, short as well as permanent disability and accidents</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">excellent training and career development opportunites as well as support with furthering your education</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">strong support from Line Management and more than 20'000 colleagues worldwide</span></li><li style="color: #333740; margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years</span></li></ul><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"><strong>Your responsibilities:</strong></span></p><ul><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Own all aspects of site management as described in the project plans.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents. Monitor data for missing or implausible entries.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Review progress of projects and initiate appropriate actions to achieve target objectives.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Act as a primary contact for clinical trial suppliers and other vendors.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Own the entire process of Serious Adverse Event (SAE) reporting</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems </span></li></ul><h2>Education/Qualifications:</h2><ul style="margin-top: 0cm;"><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, oecotrophology etc. </span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">In lieu of the above, a valid certification in health / life sciences by an accredited institute</span></li></ul><h2>Experience:</h2><ul><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Professional experience in a related function, e.g. as site manager, (inhouse) CRA, study nurse, research nurse, submission specialist, study start up specialist etc.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">First independent site monitoring and / or submission experience in France</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Familiarity with applicable French regulations and authorities governing clinical trials</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Awareness of applicable regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines</span></li><li style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif; font-size: 10pt;">IT literate, including Microsoft Word, Excel, PowerPoint and preferably eTMF solutions such as Veeva Vault</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Effective time management and organizational skills and a keen attention to detail</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders</span></li><li style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif;"><span style="font-size: 10pt;"><strong>Business fluency in French - both spoken and written - as well as a good command of English is a must</strong></span></span></li></ul><p style="margin: 0px;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">#LI-AR1</span></p>

Job posted: 2021-11-17

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