Syneos Health
Life Sciences
CRAII/SrCRA
“CRAII / Sr CRA at Syneos Health. Skills: Site qualification, Site initiation, Interim monitoring, Site management. 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 goals; Meet project objectives, deliverables and timelines; Achieve goals / targets
Industry & Context.
Problem solvers; Apply query resolution techniques; Develop action plans
Ability to manage required travel of up to 75% on a regular basis, US ONLY: Compliance with site-specific medical and personal information requests for facility access
What They're Looking For.
Must Have
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, Must demonstrate good computer skills and be able to embrace new technologies, Ability to manage required travel of up to 75% on a regular basis
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 and documentation
Protect subject/patient confidentiality
Assess factors affecting subject/patient 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 contents with TMF
Ensure investigator site awareness of essential document archiving requirements
Document activities via confirmation letters
Support subject recruitment
and awareness strategies
Enter data into tracking systems
Understand project scope
and manage site-level activities
Adapt to changing priorities to achieve goals
Act as primary liaison with study site personnel
Ensure assigned sites and project-specific 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
Provide site support throughout 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 representation; Collaborate with Sponsor affiliates; Collaborate with medical science liaisons; Collaborate with local country staff
Communication Scope
Excellent communication, presentation and interpersonal skills
Process & Methodology
Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met, Understand project scope, budgets
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