Clinical Trial Associate (Boston, MA)
- Boston, United States
- Clinical Trial Support
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
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As a Clinical Trial Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned
clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of
essential study documentation, including the electronic Trial Master File (eTMF). This position will work with
internal team members and with external vendors and CROs. The position reports to the Clinical Operations
Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical
operations activities.
• Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day
operational activities of assigned trials to ensure study objectives and timelines are met with quality, in
compliance with applicable SOPs and regulatory guidelines
• Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study
or 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 access
to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site
Staff)
• Coordinate Project Team and departmental meetings, including associated documentation
• Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders
and invoices for assigned trials
• Develop and maintain strong, collaborative relationships with key stakeholders within Moderna, its
CROs, and clinical sites
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 to
ensure 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 environment
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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