SSU CRA I - Seville. FSP.
Job Description
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
Purpose: Site relationship management role to ensure sustainable trial start-up at Site.
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Accountabilities
• Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
• Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
• Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
• Conducts site selection visits, verifies site eligibility for a specific study
• Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
• Facilitates the preparation and collection of site and country level documents
• Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
• Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities
• Prepares and finalizes site specific documents for submission
• Negotiates investigator payments, as needed
• Supports preparation of financial contracts between the client and investigational sites and investigators, as needed
• Updates all systems until site Green Light on an ongoing basis
• Supports preparation of audits and inspections, as applicable
• Supports reduction of formal site-specific IRB/IEC deficiencies
• Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are aligned with the the client strategy
• Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to the SSU Manager for review and approval
Activities & Interfaces:
• Externally facing role with impact on Principal Investigators and Institution/Site business offices.
• External engagements with vendor partners to lead site issue resolution as needed.
• Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility at time of site initiation.
Key Performance Indicators:
1. Performs against study commitments at the site level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, RIS, SIV) and data quality requirements
2. Delivers study milestones in accordance with prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
3. Actively shares insights with relevant internal stakeholders to drive site and account development
4. Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.