Study Start Up Associate II

As a Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Lead study start-up activities in collaboration with local team.
• Execute CDA (as needed)​
• Manage local translations​ as needed
• Compile and distribute startup packages and collect site startup documentation​
• Includes completion of site-specific informed consent form (as relevant) and completion of Gemstone Informed Consent tracker​
• Collaborate with site on local IRB/committee submissions​
• Compile and distribute ISF documents​
• Manage greenlight process​
• Conduct local document quality checks​
• Conduct debarment checks
• Coordinate local study communications (internal and external)​
• Coordinate provision/return/destruction of study supplies (g.PRR materials, Kits4Life, kits, etc.)​
• Maintain study-relevant systems (incl. Gemstone, vendor systems and tools). Ensuring data and document completeness and quality at the site and country level
• Complete relevant post-site close out visit activities (g.ensure provision of EOSPDF, treatment allocation, related tasks)
• Provide input to site activation strategy (i.e. potential sites for early activation)

You are:

• Healthcare related bachelor's degree or equivalent or have a combination of education and minimum 2 years of clinical operations experience.
• Awareness & understanding of cultural and regional differences
• Oral presentation & interpersonal skills
• Decision making
• Issue resolution
• Planning and organization, time management, prioritization
• Thrives in ambiguous and collaborative environments and embraces change
• Effective written and verbal English communication skills
• Willingness to travel when business requires (e.g. office meetings, study meetings, local and/or international level)

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.