Syneos Health
life sciences
CRASSU
“CRA SSU at Syneos Health. Skills: monitoring, regulatory, site management. Perform site qualification. Perform site initiation”
What You'll Achieve.
accelerate customer success; achieve goals; achieve targets; drive query resolution to closure within agreed timelines; shape solutions that have the ability to dramatically impact someone’s life; driving impact for customers; defining the pace of patient progress
Industry & Context.
problem solvers; Develop action plans; query resolution techniques
Ability to manage required travel of up to 75% on a regular basis, US ONLY: Site access requirements, US ONLY: Comply with Site requests for information
What They're Looking For.
Must Have
Knowledge of Good Clinical Practice/ICH Guidelines, Knowledge of other applicable regulatory requirements, Demonstrate good computer skills, Embrace new technologies, Ability to manage required travel of up to 75% on a regular basis
Nice to Have
Experience in monitoring, Experience in regulatory, Sponsor dedicated, Knowledge of local requirements for real world late phase study designs, Chart Abstraction activities, Data collection, Collaboration with Sponsor affiliates, Collaboration with medical science liaisons, Collaboration with local country staff
What You'll Do.
Perform site qualification
Perform site initiation
Perform interim monitoring
Perform site management
Perform close-out visits
Ensure regulatory compliance
Ensure ICH-GCP compliance
Ensure GPP compliance
Ensure protocol compliance
Evaluate overall site performance
Communicate serious issues
Maintain working knowledge of guidelines
Verify informed consent process
Protect subject confidentiality
Assess factors affecting subject safety
Assess factors affecting data integrity
Assess protocol deviation/violations
Assess pharmacovigilance issues
Assess site processes
Conduct Source Document Review
Verify CRF data accuracy
Verify CRF data completeness
Apply query resolution techniques
Provide guidance to site staff
Drive query resolution
Utilize hardware and software
Verify site compliance
Perform IP reconciliation
Verify IP administered
Ensure IP is appropriately labelled
Ensure IP is appropriately imported
Ensure IP is appropriately released/returned
Review Investigator Site File
Reconcile ISF with TMF
Ensure investigator site awareness
Support subject recruitment
Support subject retention
Support subject awareness strategies
Enter data into tracking systems
Understand project scope
Understand project budgets
Manage site-level activities
Manage site-level communication
Ensure project objectives are met
Ensure project deliverables are met
Ensure project timelines are met
Adapt to changing priorities
Act as primary liaison
Train site team members
Ensure site team compliance
Prepare for Investigator Meetings
Attend Investigator Meetings
Attend sponsor face to face meetings
Participate in global meetings
Attend clinical training sessions
Provide guidance towards audit readiness
Support audit preparation
Support audit follow-up actions
Perform chart abstraction
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Innovating as a team; Collaborate with project team; Collaborate with another CRA; Collaborate with Central Monitoring Associate; Collaborate with Sponsor representation; Collaborate with Sponsor affiliates; Collaborate with medical science liaisons; Collaborate with local country staff
Communication Scope
Excellent communication skills; Excellent presentation skills; Site communication
Process & Methodology
Manage site-level activities, Manage site-level communication, Ensure project objectives are met, Ensure project deliverables are met, Ensure project timelines are met
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