Regulatory Specialist I (Site Activation and Maintenance)

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

• Initiate investigator site activities, including:

• collection and submission of regulatory documents

• customization and negotiation of informed consent form (ICF) documents

• serve as the point of contact for a site’s institutional review board (IRB)

• track and ensure site compliance to required training

• Study regulatory maintenance activities including, but not limited to:

• Informed Consent Form (ICF) updates resulting from amendments and addenda, IB/Risk profile changes, etc.

• Management of site changes:

• Personnel (PI, Sub-I, Study Coordinators, etc.)

• Location

• Site-specific recruitment, patient facing material, and patient reimbursement

• Effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites

• Identify, communicate, and resolve issues

• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

• Leverage previous site / review board engagements to efficiently drive new work

• Populate internal systems to ensure accuracy of trial / site performance

• Populate Trial Master Files and libraries for future reference

• Provide feedback and shared learning for continuous improvement

• Leverage trial prioritization

• Anticipate and monitor dynamically changing priorities

Your profile

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred

• Understanding of the overall clinical development paradigm and the importance of efficient site activation

• Applied knowledge of project management processes and skills

• Appreciation of / experience in compliance-driven environment

• Effective communication, negotiation, and problem-solving skills

• Self-management and organizational skills

• Management of roughly 25-30 sites in regulatory activation per FTE

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 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.

Are you a current ICON Employee? Please click here to apply