Syneos Health
life sciences
SrCRAI
Neural analysis suggests this role is
optimal for Senior candidates.
“SrCRA I at Syneos Health. Skills: clinical trials, site management, ICH-GCP. Perform site qualification, initiation, monitoring, management and close-out visits. Ensure regulatory, ICH-GCP and/or GPP and protocol compliance”
What You'll Achieve.
accelerate customer success; navigate complexity, anticipate change and accelerate progress; achieve their goals; shape solutions that have the ability to dramatically impact someone’s life; driving impact for customers and defining the pace of patient progress; ensure project objectives, deliverables and timelines are met; achieve goals / targets
Industry & Context.
Basic level of critical thinking skills expected; Develops action plans
Ability to manage required travel of up to 75% on a regular basis
What They're Looking For.
Must Have
background in oncology clinical trials, High English level, 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, Basic level of critical thinking skills expected, Ability to manage required travel of up to 75% on a regular basis
What You'll Do.
Perform site qualification
management and close-out visits
ICH-GCP and/or GPP and protocol compliance
Evaluate site performance and provide recommendations
Communicate/escalate serious issues to 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
storage and security reviews
Verify IP dispensed and administered per protocol
Review IP issues or risks
Ensure IP is appropriately (re)labelled
imported and released/returned
Review Investigator Site File for accuracy
timeliness and completeness
Reconcile ISF with Trial Master File
Ensure investigator/physician site is aware of document archiving requirements
Document activities via confirmation letters
Support subject/patient recruitment
retention and awareness strategies
Enter data into tracking systems
Manage site-level activities/communication to meet project objectives
Adapt to changing priorities
Act as primary liaison with project site personnel
Ensure assigned sites and project-specific site team members are trained
Prepare for and attend Investigator Meetings
Participate in global clinical monitoring/project staff meetings
Attend clinical training sessions
Provide guidance towards audit readiness standards
Support preparation for audit and follow-up actions
Provide training or mentorship to junior CRAs
Perform training and sign off visits for junior CRA staff
Perform clinical operations lead tasks under supervision
Support site throughout study lifecycle
Perform chart abstraction activities and data collection
Collaborate and build relationships with Sponsor and affiliates
Identify and communicate out of scope activities
Proactively suggest potential sites
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team
Participate in bid defense meetings
How You'll Work.
Team & Collaboration
collaborate with passionate problem solvers, innovating as a team; collaborate with project site personnel; collaborate with Central Monitoring Associate; collaborate with RWLP Regulatory team
Communication Scope
Excellent communication, presentation and interpersonal skills
Process & Methodology
manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
Full Job Description
SrCRA I. Barcelona or Madrid. FSP. Strong background in oncology clinical trials. 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 and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/
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