Syneos Health
Life Sciences
ClinicalTrialassociate
“Clinical Trial associate at Syneos Health. Skills: Clinical trial monitoring, Site management, 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 and accelerate progress; Help our customers achieve their goals; Shape solutions that have the ability to dramatically impact someone’s life; Drive impact for customers; Define the pace of patient progress; Ensure project objectives, deliverables and timelines are met; Achieve goals / targets
Industry & Context.
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: 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
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience, Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, Must demonstrate good computer skills and be able to embrace new technologies, Excellent communication, presentation and interpersonal skills, 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 per protocol
Verify issues or risks associated with blinded or randomized IP information
Ensure IP is appropriately labelled
Review Investigator Site File for accuracy
Reconcile ISF with Trial Master File
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/targets
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/project staff meetings
Attend clinical training sessions
Provide guidance towards audit readiness standards
Support preparation for audits and follow-up actions
Complete assigned training as required
Provide site support throughout the study lifecycle
Perform chart abstraction activities and data collection
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, innovating as a team; Collaborate with Central Monitoring Associate; Collaborate with Sponsor affiliates, medical science liaisons and 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
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