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

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Job Overview

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

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.

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!

What We Have To Offer

• flexible working hours, capped overtime and compensatory time off in lieu
• 100% home-based, permanent employment contract
• travel time = work time
• highly competitive compensation packages including Christmas and vacation allowances
• regular, merit-based salary adjustments
• significant employer contribution to an attractive pension scheme
• excellent training and career development opportunites as well as support with furthering your education
• 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 Main Responsibilities

• 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
• 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 diligently reviewing source documents and monitoring the data for missing or implausible entries
• Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
• Act as a central point of contact for clinical trial suppliers and other vendors supporting your studies
• Own the entire process of Serious Adverse Event (SAE) reporting pertaining to your studies
  

Education/Qualifications

• Degree in a relevant field such as life sciences, (veterinary) medicine, pharmacology, biology, chemistry, health care, health management, nursing, oecotrophology etc.,
• 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)
  

Experience

• Professional experience in a related function, e.g. as site manager, (inhouse) CRA, study nurse, research nurse, submission specialist, study start up specialist etc.
• First independent (remote) site monitoring experience in Germany
• Familiarity with applicable German and international regulatory requirements such as GCP / ICH
• 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 diverse internal and external stakeholders
• Business fluency in German - both spoken and written - as well as a good command of English are a must
  Remote
  
  2021-58279
  
  Covance is proud to be an Equal Opportunity Employer:
  
  As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.