Informed Consent Specialist II

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Role Summary

Prepare, review, approve, process and track Subject Information Sheets (SIS) and Informed Consent Forms (ICF) required for study site activation and study conduct in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

Responsibilities

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines related to Informed Consent requirements and ICON systems.
• Perform timely and accurate task progress communication and data entry of all relevant SIS & ICF activities into the appropriate tracking system.
• For specific projects, may serve as the main point of contact with Sponsor, SSU Project Manager or Clinical Trial Manager, other functional leads and third parties.
• Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
• Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory and language requirements affecting ICFs, particularly, for assigned Countries.
• Develop and update training documentation and conduct group trainings in the assigned areas of expertise.
• If applicable, coordination of all necessary translations required for any start-up documentation.
• Attend study team meetings as required.
• Act as a mentor/coach of new hires during their onboarding.
• Escalates any legal or clinical language discrepancies with Legal and/or SSU Project Manager/Sponsor for approval as applicable.
• Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.
• Forecast SIS & ICF approval timelines and ensure they are reflected accurately in ICON’s systems and are achieved; proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
• Ensure accuracy and completeness of ICF documents that are transferred to the project team member responsible for movement to and/or filing essential documents into the Trial Master File (TMF) during start-up and maintenance phases.
• Represent FSA at audits and inspections, represent FSA for a client, function, or region on committees and work groups to support the development and implementation of new initiatives and strategic direction of FSA.
• Responsible for performing activities that are in compliance with applicable corporate and departmental policies, standard operating procedures and operating guidelines and performing other duties as assigned by the management.
• Responsible for one or more of the following tasks related to each of the key study start-up and/or maintenance activities as assigned: Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for:
  • Global Master ICF templates for Sponsors, coordinate with SSU Project Managers through to approval by Sponsors
  • Country Master ICF templates inserting any required country elements, coordinate with SSU Project Managers through to approval by Sponsors
  • Site versions inserting adaptations required to conform to local site requirements