Labcorp Drug Development

Clinical Research Associate (CRA) II - sponsor-dedicated

08 Jul 2021
04 Aug 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Clinical Research Associate (CRA) II - sponsor-dedicated

Location: Vienna, Austria / Home Office, Austria

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 oncological therapies.

If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is the perfect opportunity.

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 this sounds exciting, apply today - we cannot wait to meet you!

As Clinical Research Associate II, 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 Labcorp or sponsor data management systems
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
  • Degree in a relevant field such as life sciences, health care (management), nursing, biology, chemistry, pharmacology, (veterinarian) medicine, oecotrophology etc.
  • In lieu of the above, a completed equivalent higher vocational education with an appropriately accredited institution (e. g. licensed study nurse, study coordinator...)
  • Proven experience in clinical research in a variety of therapeutic areas including oncology
  • Solid independent monitoring experience in Austria as CRA and familiarity with applicable local regulations and authorities
  • Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Austrian regulatory authorities landscape
  • 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 and English - both spoken and written - is a must