Clinical Research Associate (CRA) I / II - sponsor-dedicated - Romania

<h2>Job Overview:</h2><p style="margin: 0px;"><strong><span style="font-family: 'times new roman', times; font-size: 12pt;">Clinical Research Associate (CRA) I / II - sponsor-dedicated - Romania</span></strong></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;">Location: Bucharest, Romania / Home Office, Romania</span></p><p aria-hidden="true" style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;">In this role, you will work directly with one of our renowned key sponsors, supporting them and your assigned study sites during phase I - III of clinical trials. You will have a direct impact on the development of innovative medications, improving the lives and health of patients every day. 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 aria-hidden="true" style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"><strong>What we have to offer: </strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">flexible working hours, capped overtime and compensatory time off in lieu</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">100% home-based, permanent employment contract</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">travel time = work time</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">highly competitive compensation packages</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">regular, merit-based salary adjustments</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">lunch allowances on work days</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">extensive medical coverance under our insurance plan</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">excellent training and career development opportunites as well as support with furthering your education</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">strong support from Line Management and more than 20'000 colleagues worldwide</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years</span></li></ul><p aria-hidden="true" style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;"><strong>Your main responsibilities:</strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Perform required monitoring tasks at your study sites in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports and own all aspects of study site management as described in the project plans</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">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-family: calibri, sans-serif; font-size: 10pt;">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-family: calibri, sans-serif; font-size: 10pt;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents and monitoring the data for missing or implausible entries</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Act as a central point of contact for clinical trial suppliers and other vendors supporting your studies</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Own the entire process of Serious Adverse Event (SAE) reporting pertaining to your studies</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Degree in a relevant field such as life sciences, (veterinary) medicine, pharmacology, biology, chemistry, health care, health management, nursing, oecotrophology etc.,</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">In lieu of the above, a completed vocational education in a relevant field (e.g. nursing) or equivalent professional experience in clinical research (e.g. as a study coordinator)</span></li></ul><h2>Experience:</h2><ul><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">First professional independent site monitoring experience as a Clinical Research Associate</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Experience in one or more of these therapeutic areas: diabetes, cardiovascular, inflammatory diseases, oncology a plus</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Familiarity with applicable Romanian and international regulatory requirements such as GCP / ICH</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Working knowledge of Microsoft Word, Excel and PowerPoint</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Effective time management and organizational skills and a keen attention to detail</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;">Ability to establish and maintain effective, trustful working relationships with diverse internal and external stakeholders</span></li><li><span style="font-family: calibri, sans-serif; font-size: 10pt;"><strong>Business fluency in Romanian - both spoken and written - as well as a good command of English are a must</strong></span></li></ul><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;">Remote</span></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 10pt;">#LI-AR1</span></p>