Syneos Health
Life Sciences
CRAIIMultiSponsor
“CRA II - Multi-Sponsor at Syneos Health. Skills: Site qualification, Site initiation, Monitoring, Site management. Perform site qualification. Perform site initiation”
What You'll Achieve.
Achieve goals / targets; Accelerate customer success; Navigate complexity; Anticipate change; Accelerate progress; Understand customer needs; Shape solutions; Achieve customer goals; Deliver for one another; Deliver for customers; Deliver for those in need; Shape solutions that impact life; Drive impact for customers; Define pace of patient progress
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: Comply 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, Demonstrate good computer skills, Ability to manage required travel of up to 75%
What You'll Do.
Perform site qualification
Perform site initiation
Perform interim monitoring
Perform site management
Perform close-out visits
Evaluate overall site performance
Communicate/escalate serious issues
Verify informed consent process
Protect subject confidentiality
Assess factors affecting subject safety
Assess factors affecting data integrity
Assess site processes
Conduct Source Document Review
Verify CRF completeness
Apply query resolution techniques
Drive query resolution
Perform IP reconciliation
Verify IP administered
Review Investigator Site File
Reconcile ISF with TMF
Ensure document archiving
Enter data into tracking systems
Manage site-level activities
Manage site-level communication
Ensure project objectives met
Ensure project deliverables met
Ensure project timelines met
Adapt to changing priorities
Act as liaison with study site personnel
Train site team members
Prepare for Investigator Meetings
Attend Investigator Meetings
Participate in global clinical monitoring meetings
Attend clinical training sessions
Support audit preparation
Support audit follow-up actions
Complete assigned training
Collaborate with Sponsor affiliates
Collaborate with medical science liaisons
Collaborate with local country staff
Identify out of scope activities
Communicate out of scope activities
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 skills; Excellent presentation skills
Process & Methodology
Manage site-level activities, Manage site-level communication, Ensure project objectives met, Ensure project deliverables met, Ensure project timelines met
Applying for this CRA II - Multi-Sponsor role?
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