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

The Study Start-Up Associate ( SSUA) is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor's standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.

Responsibilities:

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.

• Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.

• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines

• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable.

• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.

• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.

• Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

   

Requirements:

• BS/BA or bachelor’s degree in life sciences preferred
• Minimum 2 years relevant experience in clinical site management.
• Experience working in the pharmaceutical industry/or CRO in study site activation is an asset
• Must be fluent in Local language and in English. Multilanguage capability is an asset.
• Good technical skills and ability to learn and use multiple systems.
• Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.

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.

#LI-DS1

#LI- Hybrid