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

Employer
Labcorp
Location
Paris, France
Salary
Competitive
Start date
17 Sep 2021
Closing date
27 Sep 2021

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Job Details


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

Location: Paris, France

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:
  • flexible working hours, capped overtime and compensatory time off in lieu
  • permanent employment contract with Labcorp Drug Development
  • travel time = work time
  • highly competitive compensation packages
  • subsidized meals and transportation allowances
  • bonus schemes / profit sharing
  • regular, merit-based salary adjustments
  • significant employer contribution to an attractive pension scheme
  • extensive insurance coverage, including medical, life, short as well as permanent disability and accidents
  • excellent training and career development opportunities 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 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, 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:
  • 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 French regulations and authorities governing clinical trials
  • Previous site monitoring and / or submission experience in France
  • 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 French - both spoken and written - as well as a good command of English is a must


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Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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