Senior Clinical Research Associate II ( sCRA II ) - Switzerland

Job Overview:

• work as part of a diverse and stable team
• in-depth onboarding, including personal support from your mentor
• flexible working hours and compensatory time off in lieu
• a 100% home-based, permanent employment contract
• travel time = work time
• highly competitive compensation packages
• regular, merit-based salary adjustments
• significant employer contributions to an attractive pension scheme
• excellent training and career development opportunities
• 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

• 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 Labcorp or sponsor data management systems

Education/Qualifications:

• Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, (veterinary) medicine, nursing, etc.
• In lieu of the above, a completed vocational education or professional experience (e.g. as study nurse, study coordinator) in a relevant field
• Valid driver’s license

Experience:

• Profound professional experience in a related function as senior / lead CRA, with a focus on independent site monitoring in Switzerland
• In-depth familiarity with applicable Swiss and international regulatory requirements such as ICH / GCP
• Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and preferably in relevant software solutions for clinical trials, e.g. eTMF (e.g. Veeva Vault)
• 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 business fluent German and English – both spoken and written – are a must; French language skills a plus

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