Syneos Health
Life Sciences
CRAII/Sr.CRA(Oncology)
“CRA II / Sr. CRA (Oncology) at Syneos Health. Skills: Oncology monitoring, Clinical trial 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.
Achieve goals / targets; Ensure project objectives, deliverables and timelines are met
Industry & Context.
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-specific medical and personal information requests for facility access (US Only)
What They're Looking For.
Must Have
5 + years of monitoring experience, Strong oncology experience, Knowledge of Good Clinical Practice/ICH Guidelines, Knowledge of applicable regulatory requirements, Good computer skills, Ability to embrace new technologies, Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience, Ability to manage required travel of up to 75%
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 guidelines
Verify informed consent process and subject confidentiality
Assess factors affecting subject safety and data integrity
Assess site processes per Clinical Monitoring/Site Management Plan
Conduct Source Document Review and medical records review
Verify CRF data accuracy and completeness
Apply query resolution techniques
Drive query resolution to closure
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
Review IP issues or risks related to blinded or randomized information
Ensure IP is appropriately labelled
Review Investigator Site File for accuracy
Reconcile ISF with Trial Master File
Ensure investigator site awareness of document archiving requirements
Document activities via confirmation letters
Support subject recruitment
and awareness strategies
Enter data into tracking systems for observations and action items
Manage site-level activities and communication to meet project objectives
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 and compliant
Prepare for and attend Investigator Meetings and sponsor meetings
Participate in global clinical monitoring and project staff meetings
Attend clinical training sessions
Provide guidance on audit readiness standards
Support audit preparation and follow-up actions
Complete assigned training as required
Provide site support throughout the study lifecycle
Collect data and perform chart abstraction activities
Collaborate with Sponsor affiliates
and local country staff
Train junior staff as requested
Identify and communicate out of scope activities
Proactively suggest potential sites based on local knowledge
How You'll Work.
Team & Collaboration
Collaborate with passionate problem solvers; Innovate as a team; Collaborate with Central Monitoring Associate; Collaborate with Sponsor affiliates, medical science liaisons and local country staff
Communication Scope
Good communication skills; Presentation skills; Interpersonal skills
Process & Methodology
Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met
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