Clinical Research Associate (CRA) II, sponsor-dedicated - Home Office, Austria

<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) II, sponsor-dedicated - Home Office, Austria</strong></span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Location: Vienna, Austria / Home Office, Austria</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;">If you are looking for a position that allows you 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-family: calibri, sans-serif;"><span style="font-size: 10.0pt;">As Clinical Research Associate in our Flexible Solutions business unit, you are vital for the safe and successful delivery of clinical trials. Working exclusively with one of our renowned, international sponsors and serving as the primary liaison for your study sites and their patients, you help accelerate the </span><span style="font-size: 10.0pt; color: #232323;">development of drugs that improve the life and health of thousands of patients every day. </span><span style="font-size: 10.0pt;">Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!</span></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;"><strong><span style="font-size: 10.0pt;">What you can expect from us:</span></strong></span></p><ul style="margin-top: 0cm;"><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Rewarding work in a diverse, stable and respected company</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">a thorough onboarding with support from your personal mentor</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">flexible working hours and compensatory time off in lieu</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">permanent employment contract with Labcorp Drug Development</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">travel time = work time</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">highly competitive compensation packages</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">regular, merit-based salary adjustments</span></li><li style="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="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">excellent training and career development opportunities as well as support with furthering your education</span></li><li style="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="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;"><strong><span style="font-size: 10.0pt;">Your responsibilities:</span></strong></span></p><ul style="margin-top: 0cm;"><li style="margin-bottom: 3.0pt;"><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 style="margin-bottom: 3.0pt;"><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 style="margin-bottom: 3.0pt;"><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 Austrian regulatory requirements</span></li><li style="margin-bottom: 3.0pt;"><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 diligent source document review. Monitor data for missing or implausible entries and independently conduct CRF reviews</span></li><li style="margin-bottom: 3.0pt;"><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; prepare accurate and timely trip reports</span></li><li style="margin-bottom: 3.0pt;"><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 style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Act as a liaison for clinical trial suppliers and other vendors as needed</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Own the process of Serious Adverse Event (SAE) reporting, produce and process reports and narratives and follow up on any SAEs being reported by assigned patients / sites</span></li><li style="margin-bottom: 3.0pt;"><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><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management etc.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">In lieu of the above, a completed vocational education (e.g. study nurse, study coordinator) or equivalent professional experience / certifications</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 clinical trials (phases II and III), preferably at a CRO or pharmaceutical company and across a variety of indications</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Independent study site monitoring experience in Austria as a Clinical Research Associate ( "Klinischer Monitor" )</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">A solid understanding of applicable Austrian regulatory requirements as well as international standards such as ICH/GCP</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Comfortable using relevant software solutions such as Microsoft Office (Excel, PowerPoint, Word), study databases, eTMF (Veeva Vault), etc.</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;"><strong><span style="font-size: 10.0pt;">Business fluency in German - both spoken and written - as well as a good command of English is a must</span></strong></span></li></ul><p style="margin-bottom: 3.0pt;"><span style="font-family: calibri, sans-serif;"><strong><span style="font-size: 10.0pt;"> </span></strong></span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">#LI-AR1</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Remote</span></p>