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

Employer
Labcorp
Location
HOMEWORKING
Salary
Competitive
Start date
28 Jul 2021
Closing date
16 Aug 2021

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Job Details


Clinical Research Associate I - office-based / in-house
Location: Munich, 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 and advance the development of innovative, life-changing medications for a variety of therapies.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

If you are looking to jump-start your career in clinical research and drug development and to learn and gain exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!

In this role, your responsibilities will include:
  • Perform remote study site visits as required by the monitoring plan for your assigned studies, nurture and document site contacts as required per the study guidelines, and create contact reports for each telephone session (outbound or inbound) with your study sites
  • Serve as a point of contact for project teams and investigative sites and coordinate activities, escalations, meetings etc. with internal and external stakeholders as needed
  • Monitor the sites' performance and implement action plans for sites not meeting expectations
  • Collaborate closely with traveling CRAs to ensure all agreed-upon quality standards and regulatory requirements are being met and all submissions and reports are delivered in time
  • Support traveling CRAs in their preparation for site visits (i.e. run reports, ensure all required documents are available, follow up on action items from previous visits)
  • Perform Case Report Form reviews, generate queries where applicable and resolve any issues according to established data review guidelines on our or client data management systems
  • Assist with the coordination of study visits and the shipment of drug and ancillary supplies as well as any laboratory kits and samples that are needed at the study sites
  • Assist in submissions and notifications to German ethics committees and regulatory authorities
Education/Qualifications:

  • Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, oecotrophology, medicine, nursing etc.
  • In lieu of the above, a completed vocational education or professional experience (e.g. as study nurse, study coordinator) in a relevant field
Experience:
  • First professional experience in a related field (e.g. medical, clinical, pharmaceutical or laboratory research, data analysis, data management, technical writing...)
  • Previous experience in clinical research / drug development a definite plus
  • Basic understanding of biology and biological processes
  • Experience following protocol guidelines and/or SOPs
  • Familiarity with and/or practical application of ICH guidelines and GCP
  • Good organizational and time management skills
  • Excellent communication skills in business fluent German and English - both written and verbal - are 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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