Syneos Health
life sciences
CRAIIGermany
“CRA II Germany at Syneos Health. Skills: ICH-GCP, site management, protocol compliance. Perform site qualification. Perform site initiation”
What You'll Achieve.
accelerate customer success; navigate complexity; anticipate change; accelerate progress; achieve goals; achieve targets; drive query resolution to closure
Industry & Context.
problem solvers; query resolution techniques
Ability to manage required travel for monitoring visits
What They're Looking For.
Must Have
Knowledge of Good Clinical Practice/ICH Guidelines, Knowledge of other applicable regulatory requirements, Previous monitoring experience in Germany, good computer skills, Fluency in German, Fluency in English
Nice to Have
Ability to manage required travel for monitoring visits
What You'll Do.
Perform site qualification
Perform site initiation
Perform interim monitoring
Perform site management activities
Perform close-out visits
Ensure regulatory compliance
Ensure ICH-GCP compliance
Ensure GPP compliance
Ensure protocol compliance
Evaluate site performance
Communicate serious issues
Maintain working knowledge
Verify informed consent process
Protect subject confidentiality
Assess subject safety factors
Assess clinical data integrity
Assess site processes
Conduct Source Document Review
Verify CRF completeness
Drive query resolution
Utilize hardware and software
Verify EDC compliance
Perform IP reconciliation
Verify IP administration
Review ISF timeliness
Review ISF completeness
Reconcile ISF with TMF
Support subject recruitment
Support subject retention
Support subject awareness
Enter data into tracking systems
Understand project scope
Understand project budgets
Manage site-level activities
Manage site-level communication
Meet project objectives
Meet project deliverables
Meet project timelines
Adapt to changing priorities
Act as primary liaison
Collaborate with Central Monitoring Associate
Ensure site compliance
Prepare for Investigator Meetings
Attend Investigator Meetings
Attend sponsor meetings
Participate in global meetings
Attend clinical training sessions
Provide guidance on audit readiness
Support audit preparation
Support audit follow-up actions
Complete assigned training
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Innovating as a team; Collaborate with project team; Collaborate with Central Monitoring Associate; Participate in global clinical monitoring/project staff meetings; Attend sponsor face to face meetings
Communication Scope
Excellent communication skills; Excellent presentation skills; Excellent interpersonal skills
Process & Methodology
Manage site-level activities, Manage site-level communication, Ensure project objectives, Ensure project deliverables, Ensure project timelines
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