Syneos Health
Life Sciences
CRAII
“CRA II at Syneos Health. Skills: Site management, Clinical monitoring, Regulatory compliance. 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; Navigate complexity; Anticipate change; Accelerate progress; Achieve customer goals; Drive impact for customers; Define the pace of patient progress; Ensure regulatory, ICH-GCP and/or GPP and protocol compliance; Provide recommendations regarding site-specific issues; Drive query resolution to closure within agreed timelines; Ensure IP is appropriately (re)labelled, imported and released/returned; Ensure the investigator/physician site is aware of the requirement of archiving essential documents; Ensure project objectives, deliverables and timelines are met; Ensure all assigned sites and project-specific site team members are trained and compliant; Support preparation for audit and required follow-up actions; Complete assigned training as required
Industry & Context.
Passionate problem solvers; Uses judgment and experience to evaluate overall performance; Develops action plans; Applies query resolution techniques; Proactively suggest potential sites
Ability to manage required travel of up to 75% on a regular basis, US ONLY: Compliance with Site requests for medical and other personal information for facility access
What They're Looking For.
Must Have
Knowledge of Good Clinical Practice/ICH Guidelines, Knowledge of other applicable regulatory requirements, Good computer skills, Ability to manage required travel of up to 75%
What You'll Do.
Perform site qualification
and protocol compliance
Evaluate site and staff performance
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 and documentation
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 IP issues or risks related to blinded or randomized information
Ensure IP is appropriately (re)labelled
and released/returned
Review Investigator Site File for accuracy
Reconcile ISF contents with Trial Master File
Ensure investigator site awareness of essential document archiving requirements
Document activities via confirmation letters
and communication logs
Support subject recruitment
and awareness strategies
Enter data into tracking systems
Manage site-level activities and communication to meet project objectives
Adapt to changing priorities to achieve goals
Act as primary liaison with study site personnel
Ensure assigned sites and project-specific site team members are trained and compliant
Prepare for and attend Investigator Meetings and sponsor meetings
Participate in global clinical monitoring and project staff meetings
Attend clinical training sessions
Provide guidance on audit readiness standards
Support preparation for audits and required follow-up actions
Complete assigned training as required
Provide site support throughout the study lifecycle
Collaborate with Sponsor affiliates
medical science liaisons
and local country staff
Identify and communicate out of scope activities
Proactively suggest potential sites
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Collaborate with project team; Collaborate with Central Monitoring Associate; Collaborate with Sponsor affiliates; Collaborate with medical science liaisons; Collaborate with local country staff
Communication Scope
Excellent communication skills; Excellent presentation skills
Process & Methodology
Manage site-level activities, Manage communication, Ensure project objectives are met, Ensure deliverables are met, Ensure timelines are met
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