Study Start Up Specialist -Home based

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Summary

This in-house position is responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving ICFs (Informed Consent Forms) for IRB/IEC submissions for assigned clinical sites.

Principal Responsibilities

• Accountable for site start-up for assigned clinical sites
• Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with IRB/IEC submissions
• Sends start-up packets
• Reviews and approves ICFs pre- and post-IRB/IEC submission
• Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Seagen processes and timelines
• Assists in resolution of site queries for assigned clinical sites
• Provides regular updates and escalates site issues to SSU Manager
• May attend weekly start-up meetings with SSU Manager, PL, CCM, Legal, and other key stakeholders as necessary
• Forecasts and tracks metrics and progress of site start-up for assigned clinical sites, ensuring all sites are greenlit on time per SSU timelines
• Ensures metrics in clinical trial management systems are up to date and accurate
• Ensures site essential documents are uploaded to eTMF accurately and on time for site greenlight
• Prepares greenlight packets for assigned clinical sites
• Performs second review of essential documents and/or ICFs for other members of the SSU team
• Mentors junior SSU Team members

Benefits of Working in ICON:

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.

At 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.

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, 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.