Syneos Health
biopharmaceutical
CRASwitzerland
“CRA Switzerland at Syneos Health. Skills: Clinical monitoring, Site management, Regulatory compliance, ICH-GCP. Perform site qualification, initiation, monitoring, management, and close-out visits. Ensure regulatory, ICH-GCP, GPP, and protocol compliance”
What You'll Achieve.
Accelerate customer success; Address modern market realities; Achieve goals; Achieve targets
Industry & Context.
Problem solvers
Travel to Austria and Germany, Manage required travel for monitoring
What They're Looking For.
Must Have
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience, Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, Previous monitoring experience, Must demonstrate good computer skills and be able to embrace new technologies, Excellent communication, presentation and interpersonal skills, German and French speaking, Proficient in English
What You'll Do.
Perform site qualification
and protocol compliance
Evaluate site performance and provide recommendations
Communicate and escalate serious issues to the project team
Develop action plans for site issues
Maintain working knowledge of ICH/GCP Guidelines
Verify informed consent process adequacy
Protect subject confidentiality
Assess factors affecting subject safety and data integrity
Assess site processes per Clinical Monitoring/Site Management Plan
Conduct Source Document Review
Verify CRF data accuracy and completeness
Apply query resolution techniques
Provide guidance to site staff for query resolution
Utilize hardware and software for data review and capture
Verify site compliance with electronic data capture requirements
Perform investigational product inventory
Verify IP dispensing and administration according to protocol
Review Investigator Site File for accuracy
Reconcile ISF with TMF
Ensure investigator site awareness of document archiving requirements
Document activities via confirmation letters
Support subject recruitment
and awareness strategies
Enter data into tracking systems
Manage site-level activities and communication
Adapt to changing priorities
Act as primary liaison with study site personnel
Ensure assigned sites and project-specific site team members are trained
Prepare for and attend Investigator Meetings
Participate in global clinical monitoring/project staff meetings
Attend clinical training sessions
Provide guidance on audit readiness standards
Support preparation for audits and follow-up actions
Complete assigned training as required
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Innovate as a team; Work with project team; Collaborate with Central Monitoring Associate; Work with Sponsor representation
Communication Scope
Excellent communication skills; Presentation skills; Interpersonal skills
Process & Methodology
Manage site-level activities, Manage communication, Ensure project objectives, deliverables and timelines are met
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