SMA II

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

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 submissions
• Sends start-up packets
• Reviews and approves ICFs pre- and post-IRB 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 SSU Study 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
• Manages time on assigned clinical sites across one or more clinical studies and escalates issues to Managers, SSU.
• May prepare and perform IRB/IEC amendment activities, as required.
• Complete training assigned including general training requirements, Operating Procedures (OP), and system and process related training.
• Adhere to OP and processes.
• Contribute to Clinical Contract and Study Start-Up quality, systems, and process initiatives.
• Support study start-up managers with diverse tasks as appropriate and as required.

You are:

• BA/BS or equivalent or any relevant and qualifying training
• Minimum of four (4) years of relevant clinical trial experience working in Pharma, Biotech or CRO environment.
• Minimum of two (2) years of clinical trial or equivalent Start-Up unit experience.
• Thorough knowledge of clinical start-up process and requirements required
• Knowledge of CFR and GCP/ICH 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
• Oncology clinical research experience, preferred.
• Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint
• Proficiency in English written and verbal communication.

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.