Clinical Research Associate II - office-based / in-house

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: 'times new roman', times; font-size: 12pt;"><strong>Clinical Research Associate II - office-based / in-house</strong></span></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: 10pt; font-family: calibri, sans-serif;"> </span></p><p style="margin: 0px;"><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 70,000 employees advance life-changing medicines across a wide range of therapeutic areas. </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">In this role, you will work with our renowned key sponsors and advance the development of innovative, life-changing medications for a variety of therapies. 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: .0001pt;"> </p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt;"> </span></strong></p><p style="margin: 0px;"><span style="font-family: 'times new roman', times;"><strong><span style="font-size: 10pt;">What we have to offer:</span></strong></span></p><ul><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">work as part of a diverse and stable team</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">in-depth onboarding, including personal support from your mentor</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">flexible working hours, capped overtime and compensatory time off in lieu</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">a permanent employment contract</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">travel time = work time</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">highly competitive compensation packages including Christmas and vacation allowances</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">regular, merit-based salary adjustments</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">significant employer contributions to an attractive pension scheme</span></li><li><span style="font-size: 10pt; color: #333740; font-family: calibri, sans-serif;">excellent training and career development opportunities</span></li><li><span style="font-size: 10pt; color: #333740; 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; color: #333740; 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;"> </p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Your responsibilities:</span></strong></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-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;">Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare 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;">Interact with internal work groups to evaluate needs, resources and timelines</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Act as contact for clinical trial suppliers and other vendors as assigned</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">Independently perform CRF reviews</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 life sciences, pharmacology, biology, chemistry, health care, health management, (veterinary) medicine, nursing, etc.</span></li><li><span style="font-size: 10pt; font-family: calibri, sans-serif;">In lieu of the above, a completed vocational education or professional experience (e.g. as study nurse, study coordinator) in a relevant field</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;">Professional experience in a related function with a focus on independent site monitoring in Germany </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 and 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 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><p style="margin: 0px;"><span style="font-size: 10pt; font-family: calibri, sans-serif;">Remote</span></p>