Clinical Research Associate ( CRA ) II - office-based / inhouse

<h2>Job Overview:</h2><p style="margin: 0px;"><strong><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Clinical Research Associate ( CRA ) II - office-based / inhouse</span></strong></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Location: Munich, Germany</span></p><p style="margin: 0px;"><span style="font-size: 10.0pt;"> </span></p><p style="margin-right: 1.7pt;"><span style="font-family: calibri, sans-serif;"><span style="font-size: 10.0pt;">As a CRA at Labcorp, you are central to the successful delivery of complex clinical trials (phases I-III) in Germany. </span><span style="font-size: 10.0pt;">Not only will this position allow you to stay up to date with the latest scientific breakthroughs across a wide variety of therapeutic areas, while collaborating with the most important pharmaceutical companies and the most innovative biotech organizations in the world - your work has a genuine impact on improving the health and lives of thousands of patients every day.</span></span></p><p style="margin-right: 1.7pt;"> </p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p><p style="margin: 0px;"><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><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Rewarding work in a stable, diverse, respected and highly profitable company</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">A thorough onboarding with support from your personal mentor</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Flexible working hours, capped overtime and compensatory time off in lieu</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">A permanent employment contract with Labcorp Drug Development</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Travel time = work time</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Highly competitive compensation packages, including Christmas and vacation allowances</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Regular, merit-based salary adjustments</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Significant employer contribution to an attractive pension scheme</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Excellent training and career development opportunities as well as support with advancing your education</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">A genuine work life balance</span></li><li><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><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: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p><p style="margin: 0px;"><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><span style="font-size: 10pt; font-family: calibri, sans-serif;">Own all aspects of site management as described in the project plans. Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines and submit accurate and timely trip reports.</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. 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;"><span style="font-size: 10.0pt;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. </span><span style="font-size: 10.0pt;">Monitor data for missing or implausible entries.</span></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 in close interaction with other Labcorp teams to evaluate needs, resources and timelines</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Act as a point of 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, process production of reports, narratives and follow ups on SAEs</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><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, biochemistry, etc. </span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">In lieu of the above, an equivalent completed vocational education in the health care / life sciences industry or equivalent professional experience</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Valid driver's license</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Independent monitoring experience in Germany as a Clinical Research Associate / CRA / Site Monitor</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Familiarity with applicable German and international regulatory requirements such as ICH / GCP</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and preferably in relevant software solutions for clinical trials, e.g. eTMF (e.g. Veeva Vault)</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Effective time management and organizational skills as well as a keen attention to detail</span></li><li><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><span style="font-family: calibri, sans-serif;"><strong><span style="font-size: 10.0pt;">Excellent communication skills in business fluent German and and a good command of English – both spoken and written – are a must</span></strong></span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">#LI-AR1</span></p>