Job Overview :
Senior) Clinical Research Associate (s)CRA - sponsor-dedicated
Location : Vienna, Austria / Home Office, Austria
Covance has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today.
Our highly dedicated, supportive teams work on bringing drugs to market that have a real impact on the lives and health of people.
Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
What we have to offer : a strong international support network, flexible working solutions that enable a genuine work-life balance, a highly competitive compensation package and the opportunity to 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 getting to know you!
Your responsibilities will include :
Full responsibility for 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 data
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 review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
Assist with training, mentoring and development of new employees, e.g. co-monitoring
Education / Qualifications :
Degree in a relevant field such as biology, life sciences, pharmacology, (veterinarian) medicine, oecotrophology etc. or an equivalent scientific or commercial Higher Vocational education (e.
g. study nurse, study coordinator) plus additional training as CRA
Professional experience in clinical research, preferably in a CRO or a pharmaceutical company
Previous monitoring experience in Austria including familiarity with applicable Austrian regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and the local regulatory authorities
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