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

☞ Labcorp Drug Development

View: 173

Update day: 24-10-2024

Location: Munich Bavaria

Category: R & D IT - Software

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job Overview

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
    2021-71080

    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.
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Deadline: 08-12-2024

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