SMA II

Overview:

The Study Start-Up Specialist is responsible for supporting Site Start-Up activities, including collection and
review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics
committee submissions for assigned clinical sites.

What you will be doing:

• 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 - ethics committee submission.
• Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in
accordance with processes and timelines.
• Assists in resolution of site queries for assigned clinical sites.
• Provides regular updates and escalates site issues to Manager, SSU.
• May attend weekly Start-Up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts
Manager (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 Study Start-Up timelines.
• Ensures metrics in clinical trial management systems are up to date and accurate.
• Ensures site essential documents are uploaded to electronic Trial Master File (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 Study Start-Up
Team.
• Mentors junior Site Start-Up Team members.
• Manages time on assigned clinical sites across one or more clinical studies and escalates issues to
Managers, SSU.

You are:

• Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
• Minimum of 3 years of relevant clinical trial experience.
o Minimum of 3-5 years of pharmaceutical or biotechnology industry, preferred.
• Thorough knowledge of clinical Start-Up process and requirements required.
• Knowledge of CFR and ICH/GCP requirements is required.
• Requires effective organizational and time management skills.
• Able to multi-task under limited direction and on own initiative.
• Strong communication and inter-personal skills.
• Highly responsive and proactive, a team player.
• Previous Start-Up unit experience, preferred.
• Oncology clinical research experience, preferred.
• Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint

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.