Unblinded Clinical Research Associate (uCRA) - sponsor-dedicated
covance
Vienna, Austria
vor 2 Tg.

Job Overview :

Unblinded Clinical Research Associate (uCRA) - sponsor-dedicated

Location : Home Office, Austria

A formula for clinical innovation : Covance + LabCorp. 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.

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 broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!

As uCRA, you typically will :

  • Own all aspects of pharmaceutical site management as described in the project plans
  • Ensure accurate pharmacy documentation
  • Maintain investigational medicinal product (IMP) accountability
  • Ensure blinded and unblinded site staff members can work in a coordinated manner without compromising the blinded monitors
  • Oversee that IMP supplies are maintained in suitable storage conditions and are accurately reconstituted, dispensed, administered, returned and destroyed
  • Review Case Report Forms (CRF), generate queries and resolve issues in accordance with established data review guidelines on Covance or client data management systems
  • Education / Qualifications :

  • Degree in a relevant field such as life sciences, biology, pharmacology, (veterinarian) medicine, oecotrophology etc. or an equivalent scientific or commercial Higher Vocational education (e.
  • g. study nurse, study coordinator)

    Experience :

  • Experience in clinical research
  • Previous monitoring experience in a comparable function (uCRA or CRA) in Austria, including familiarity with applicable Austrian regulations and authorities
  • Awareness of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (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 internal and external stakeholders
  • Business fluency in German - both spoken and written - as well as a good command of English are a must
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