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

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

Location: Vienna, Austria / Home Office, Austria

A formula for clinical innovation: Covance by 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
• Own the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on 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, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, oecotrophology etc.
• In lieu of the above, a completed equivalent vocational education (e.g. study nurse, research nurse, study coordinator...) and/or equivalent professional experience

Experience:

• Proven experience in clinical research in a variety of therapeutic areas including oncology
• Solid independent monitoring experience in Austria as (Senior / Lead) CRA and familiarity with applicable Austrian 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
• Excellent communication skills in both German and English -spoken and written - are a must

Remote

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