Study Start-Up Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• During feasibility, run GSAM Flag report to check that investigator is not on the list
• Assist in the creation, distribution and tracking of investigator feasibility questionnaires
• Follow up with sites to collect and correct feasibility questionnaires
• Collection of confidentiality disclosure agreements (CDA) from interested sites during feasibility process
• Conduct feasibility process by contacting potential investigational sites and collecting questionnaire data.
• Collection and review of regulatory documents for accuracy and completeness, including QC review of internal team members' review
• Conduct first line review of essential regulatory documents including FDA Form 1572, IRB approvals, financial disclosures, CVs/licensure, etc. per the Sponsor's SOPs
• Interact with site and study personnel regarding records management and site start-up activities, including follow-up on discrepancies
• Prepare final regulatory package using Bayer's SOPs and required SOPs
• Coordination, tracking and distribution of relevant sponsor documentation prior to tRB approval (i.e. INO safely alerts) and the SIV.
• Liaise with internal personnel on trial documents and site readiness
• Obtain approval of informed consent changes so that study timelines are met
• Maintain updates and accuracy of sites information in client trial management system
• Provide Investigators with Investigator Site Binders
• Preparation and distribution of site start up materials
• Assist in the creation of initial site files for Trial Master File (TMF)
• Assist with QC audits of TMF during Start-Up period following Clients SOPs
• Assist with mentoring/training of new staff where appropriate
• Attend and participate in team meetings

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You are:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed health-care professional (e.g., registered nurse) required, preferably with 3 years relevant clinical research experience.

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/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.