Clinical Research Associate (CRA I / CRA II) - sponsor-dedicated
Location: Home Office, Switzerland
A formula for clinical innovation: Covance + 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 a variety of 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 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
- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform CRF reviews
- Generate queries and resolve issues according to data review guidelines on Covance or sponsor data management systems
- Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, oecotrophology etc., or an equivalent vocational education (e.g. study nurse, study coordinator)
- First professional experience in a related function, e.g. as site manager, study coordinator, project coordinator, (inhouse) CRA, study nurse, research nurse, submission specialist, study start up specialist etc.
- Familiarity with applicable Swiss regulations and authorities governing clinical trials
- Previous site monitoring and / or submission experience in Switzerland
- Awareness of applicable regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 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, additional language skills in French and/or Italian a definite plus