(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated
covance
Vienna, Austria
vor 5 Std.

Job Overview :

Senior) Clinical Research Associate (s)CRA - sponsor-dedicated

Location : Vienna, Austria / 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 for oncological 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 broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!

As (Senior) Clinical Research Associate, you typically will :

  • 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 Covance or sponsor data management systems
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
  • Education / Qualifications :

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

    Experience :

  • Solid experience in clinical research in a variety of therapeutic areas including Oncology
  • Previous monitoring experience in Austria and 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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