Syneos Health
Life Sciences
CRAII
Neural analysis suggests this role is
optimal for Mid+ candidates.
“CRA II at Syneos Health. Perform site qualification, initiation, monitoring, management, and close-out visits. Evaluate site performance and provide recommendations”
What You'll Achieve.
Accelerate customer success; Navigate complexity; Anticipate change; Accelerate progress; Achieve customer goals; Deliver for one another, customers, and those in need; Shape the future of healthcare; Driving impact for customers; Defining the pace of patient progress; Ensure regulatory, ICH-GCP and/or GPP and protocol compliance; Drive query resolution to closure within agreed timelines; Ensure IP is appropriately (re)labelled, imported and released/returned; Ensure the investigator/physician site is aware of the requirement of archiving essential documents; Ensure all assigned sites and project-specific site team members are trained and compliant; Ensure project objectives, deliverables and timelines are met; Achieve goals / targets; Support subject/patient recruitment, retention and awareness strategies; Ensure site compliance with applicable requirements; Support preparation for audit and required follow-up actions
Industry & Context.
Passionate problem solvers; 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: Compliance with site-specific medical and personal information requests for facility access
What They're Looking For.
Must Have
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
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
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 on 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 according to 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 contents with TMF
Ensure investigator/physician site awareness of archiving requirements
Document activities via confirmation letters
Support subject/patient recruitment
and awareness strategies
Enter data into tracking systems
Manage site-level activities and communication to meet project objectives
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 on 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 project team; Collaborate with Central Monitoring Associate; Collaborate with Sponsor affiliates, medical science liaisons and local country staff
Communication Scope
Excellent communication skills
Process & Methodology
Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met
Full Job Description
CRA II - Shanghai Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. **Job Responsibilities** * Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and proto
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