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Site Activation and Maintenance Associate I

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iconplc

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Location:
United States , Raleigh ▼

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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 we offer:
  • 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

Additional Information:

Job Posted:
March 22, 2026

Work Type:
Remote work
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