Senior Informed Consent Specialist

Informed Consent Specialist II - Warsaw, Poland - Office or Homebased

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.

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

What you need:

• Bachelor’s Degree
• 3-6 years of experience in a Clinical Research environment
• Must have proven experience in preparing, reviewing, approving, processing, customizing and tracking Informed Consent Forms (ICF) in accordance with applicable SOPs, country regulations/guidelines, and ICH/GCP
• Good communication skills
• Good Judgment & Decision Making
• Proficiency in English and language required for country assignments

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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