Clinical Research Associate (CRA) II - sponsor-dedicated - Austria

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 - improving health and lives every day.

If you are looking for a position that allows you to broaden your therapeutic expertise, whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity!

As Clinical Research Associate in our Flexible Solutions business unit, you are vital for the safe and successful delivery of clinical trials. Working exclusively with one of our renowned, international sponsors and serving as the primary liaison for your study sites and their patients, you help accelerate the development of drugs that improve the life and health of thousands of patients every day. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!

What you can expect from us:

• Rewarding work in a diverse, stable and respected company
• a thorough onboarding with support from your personal mentor
• flexible working hours and compensatory time off in lieu
• permanent employment contract with Labcorp Drug Development
• travel time = work time
• highly competitive compensation packages
• regular, merit-based salary adjustments
• significant employer contribution to an attractive pension scheme
• excellent training and career development opportunities as well as support with furthering your education
• strong support from Line Management and more than 20'000 colleagues worldwide
• the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years

Your responsibilities:

• 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 Austrian regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligent source document review. Monitor data for missing or implausible entries and independently conduct CRF reviews
• 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
• Act as a liaison for clinical trial suppliers and other vendors as needed
• Own the process of Serious Adverse Event (SAE) reporting, produce and process reports and narratives and follow up on any SAEs being reported by assigned patients / sites
• Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

Education/Qualifications:

• Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management etc.
• In lieu of the above, a completed vocational education (e.g. study nurse, study coordinator) or equivalent professional experience / certifications

Experience:

• Professional experience in clinical trials (phases II and III), preferably at a CRO or pharmaceutical company and across a variety of indications
• Independent study site monitoring experience in Austria as a Clinical Research Associate ( "Klinischer Monitor" )
• A solid understanding of applicable Austrian regulatory requirements as well as international standards such as ICH/GCP
• Comfortable using relevant software solutions such as Microsoft Office (Excel, PowerPoint, Word), study databases, eTMF (Veeva Vault), etc.
• 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 is a must

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