Job Overview :
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)
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