Clinical Trial Associate

Overview

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

Responsibilities

What you will be doing:

The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assignedclinical trial(s). This support includes tracking a wide range of key operational activities and maintenance ofessential study documentation, including the electronic Trial Master File (eTMF). This position will work withinternal team members and with external vendors and CROs. The position reports to the Clinical OperationsHead in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinicaloperations activities.

 

• Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-dayoperational activities of assigned trials to ensure study objectives and timelines are met with quality, incompliance with applicable SOPs and regulatory guidelines • Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized studyor departmental systems • Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd

party labs • Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and accessto Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical SiteStaff) • Coordinate Project Team and departmental meetings, including associated documentation • Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase ordersand invoices for assigned trials • Develop and maintain strong, collaborative relationships with key stakeholders within Moderna, itsCROs, and clinical sites

 

Qualifications

You are:

 

• At least 2 years of experience in a clinical research environment • Bachelor’s degree in a science-based discipline preferred • Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines toensure the appropriate conduct of clinical studies • Good verbal and written communication skills • Good organizational skills and attention to detail • Willingness to learn, able to take direction and ability to manage multiple tasks • Self-motivated and comfortable with shifting priorities and change in a small company environmentWhat 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/benefitsAt 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-accommodationsInterested 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