Start-Up CRA

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.

The Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials within the country. Responsible for site preparation and early identification of real site needs and issues and close handover to CRA (from issue management to risk identification).

Responsibilities:

• Collaborates with Study Start-Up Manager, Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments.
• Responsible for timely start-up activities from country allocation until site activation of assigned sites
• Conducts site selection visits, verifies site eligibility for a specific study.
• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Facilitates the preparation and collection of site and country level documents
• Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, etc.) for all relevant site personnel within agreed timelines.
• Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports assigned sites in vendor set-up activities.
• Prepare and finalize site specific documents for submission.
• Negotiates investigator payments as needed.
• Supports preparation of financial contracts between the sponsor and investigational sites and investigators as needed.
• Supports preparation of audits and inspections as applicable
• Supports reduction of formal site-specific IRB/IEC deficiencies

Requirements:

• Master’s degree in Life Sciences or equivalent
• Min. 1 year of experience in start-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
• IT proficiency: MS Office, clinical trials systems
• Fluent English and Hebrew verbal and writing skills
• Ability to build and maintain strong working relationships with internal and externalstakeholders

What 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/benefitsICON, 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 or submit a request here.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.