This page was automatically translated and accurateness of translation is not guaranteed. Please refer to the English version for a source text.

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

Laboratory Corporation of America Holdings (Covance)

Munich, Germany


Job Overview:

Clinical Research Associate (CRA) II - sponsor-dedicated - Germany

Location: Munich, Germany / Home Office, Germany

 

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.

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.

 

What you can expect from us:

  • work as part of a diverse and stable team
  • in-depth onboarding, including personal support from your mentor
  • flexible working hours, capped overtime and compensatory time off in lieu
  • a permanent employment contract
  • travel time = work time
  • highly competitive compensation packages including Christmas and vacation allowances
  • regular, merit-based salary adjustments
  • significant employer contributions to an attractive pension scheme
  • excellent training and career development opportunities
  • strong support from Line Management and more than 20'000 colleagues worldwide
  • the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years

 

Your responsibilities:

  • Own all aspects of site management as described in the project plans
  • 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
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries
  • Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial suppliers and other vendors as assigned
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF reviews
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

Education/Qualifications:

  • Degree in a relevant field such as life sciences, pharmacology, biology,  (veterinary) medicine, chemistry, health care, health management etc.
  • In lieu of the above, a completed vocational education (e.g. study nurse, study coordinator) or equivalent professional experience / certifications

Experience:

  • First professional experience in a related function, e.g. as site manager, study coordinator, project coordinator, (inhouse) CRA, study nurse, research nurse, submission specialist, study start up specialist etc.
  • Familiarity with applicable German regulations and authorities governing clinical trials
  • Previous site monitoring and / or submission experience in Germany a definite advantage
  • Awareness of applicable regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Effective time management and organizational skills and a keen attention to detail
  • Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
  • Business fluency in German - both spoken and written - as well as a good command of English is a must

 

#LI-AR1

Remote


2021-09-21 16:10:34


Apply to this job