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

Location: Home Office, Switzerland

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. If you are looking to broaden your therapeutic expertise and sharpen your leadership skills, whilst having a true impact on the lives and health of people, this is the perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

We are looking for experienced, multilingual CRAs or SCRAs to work directly with one of our renowned key sponsors, advancing the development of innovative, life-changing medications. Monitoring study sites across the country, you get to leverage your language skills in German, French and Italian on a daily basis.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

Sounds exciting? Then we would love to hear from 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, chemistry, pharmacology, (veterinarian) medicine, oecotrophology etc.
• In lieu of the above, an equivalent scientific or commercial Higher Vocational education with an appropriately accredited institution ( g. licensed study nurse, study coordinator)

Experience:

• Professional experience as (s) CRA, monitoring study sites across Switzerland
• Familiarity with applicable regulatory requirements, i.e. local regulations, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Solid computer skills, including CTMS / EDC /eTMF systems and MS Office
• 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 two of the following Swiss languages and at least a working knowledge in the third are a must: German - French - Italian, as well as a good command of English

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