
ssu cra
4 semanas atrás
Role: Study Start Up CRA (must have CRA experience or extensive SSU experience)
Location: Must be based in the UK, nationwide travel
Fully sponsor dedicated
As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
As a SSU Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. You will be responsible for site selections as well as study-specific start-up activities and deliverables of assigned sites for phase I-IV trials in the UK.
Your responsibilities include, but are not limited to: Allocation, initiation and conduct of trials:
- Support country SSU strategy in close collaboration with the SSU Team Lead, SSU Manager and the Feasibility Manager, as well as the Site Partnership Manager
- Collaborate with the SSU Manager, SSU Team Lead and global study team to ensure SSU timelines and deliverables are met according to the commitments in the UK
- Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
- Conduct site selection visits, verifies site eligibility for a specific study
- Act as the main point of contact for trial sites during site selection, study start up and IRB/IEC and HA submissions preparation
- Facilitate the preparation and collection of site and country level documents
- Collect submission-related site specific documents for all relevant site personnel within agreed timelines (e.g FD, CV, GCP certificates etc)
- Negotiate investigator payments, as needed
- Support the preparation of financial contracts between our client and investigational sites and investigators, as needed
- Support the preparation of audits and inspections
You will need the following:
• Right to work in the UK
• Up to 2 years pharmaceutical industry experience or other relevant experience (NHS or Academic)
• Good knowledge of drug development process specifically clinical trial/research
• Knowledge of international standards (GCP/ICH, FDA, EMEA)
• 12+ months' monitoring experience or 2+ years experience in a SSU type role required
Important for the role:
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
• A minimum of 50% overnight travel may be required.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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