Syneos Health
Life Sciences
CRAShanghai
“CRA - Shanghai at Syneos Health. Perform site qualification, initiation, monitoring, management, and close-out visits. Evaluate site and staff performance”
What You'll Achieve.
Accelerate customer success; Navigate complexity; Anticipate change; Accelerate progress; Achieve customer goals; Drive query resolution to closure within agreed timelines; Ensure project objectives, deliverables and timelines are met; Achieve goals / targets; Ensure all assigned sites and project-specific site team members are trained and compliant; Support preparation for audit and required follow-up actions; Drive impact for customers; Define the pace of patient progress
Industry & Context.
Problem solvers; Uses judgment and experience to evaluate overall performance; Provide recommendations regarding site-specific; Develops action plans
Ability to manage required travel of up to 75% on a regular basis, Site access may require specific medical and personal information, Compliance with Site requests for information is a condition of employment
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
Evaluate site and staff performance
Communicate and escalate serious issues to project team
Develop action plans for site issues
Maintain working knowledge of ICH/GCP Guidelines
Verify informed consent process adequacy
Protect subject confidentiality
Assess factors affecting subject safety and data integrity
Conduct Source Document Review
Verify CRF data accuracy and completeness
Apply query resolution techniques
Utilize hardware and software for data review and capture
Verify site compliance with EDC requirements
Perform investigational product inventory and reconciliation
Verify IP dispensing and administration
Review Investigator Site File for accuracy and completeness
Reconcile ISF with TMF
Ensure investigator site document archiving
Document activities via project documents
Support subject recruitment
and awareness strategies
Enter data into tracking systems
Manage site-level activities and communication
Adapt to changing priorities
Act as liaison with project site personnel
Ensure site team members are trained and compliant
Prepare for and attend Investigator Meetings
Participate in global clinical monitoring meetings
Attend clinical training sessions
Provide guidance on audit readiness standards
Support audit preparation and follow-up actions
Provide site support throughout study lifecycle
Perform chart abstraction and data collection
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Innovating as a team; Work with project team; Collaborate with Sponsor affiliates; Collaborate with medical science liaisons; Collaborate with local country staff
Communication Scope
Excellent communication skills; Communication skills
Process & Methodology
Manage site-level activities, Manage communication, Ensure project objectives are met, Ensure project deliverables are met, Ensure project timelines are met
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