Syneos Health
Life Sciences
CRAIISCRA
“CRA II- SCRA 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 targets; Drive query resolution to closure within agreed timelines; Ensure project objectives, deliverables and timelines are met
Industry & Context.
Problem solvers; Uses judgment and experience to evaluate overall performance; Develops action plans
Ability to manage required travel of up to 75% on a regular basis, Compliance with site requests for medical and other personal information for facility access (US ONLY)
What They're Looking For.
Must Have
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, Demonstrate good computer skills, Ability to manage required travel of up to 75% on a regular basis
Nice to Have
Knowledge of local requirements for real world late phase study designs
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
Verify informed consent process adequacy and documentation
Assess factors affecting subject safety and data integrity
Conduct Source Document Review
Verify CRF data accuracy and completeness
Drive query resolution to closure
Verify site compliance with electronic data capture requirements
Perform investigational product inventory
Verify IP dispensed and administered according to protocol
Review Investigator Site File for accuracy
Reconcile ISF with Trial Master File
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
Adapt to changing priorities
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 towards audit readiness standards
Support preparation for audits and follow-up actions
Maintain working knowledge of ICH/GCP Guidelines
Complete assigned training
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 innovators; 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 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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