FSA-Site Specialist Ⅰ, Site Specialist II and Senior Site 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

Role Summary:

Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON's culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

Responsibilities:

• Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
• Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
• Ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
• Support coordination of all necessary translations required for any start-up documentation.
• Proficient in timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.
• Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON's systems, proactively follow through for achievement to plan.
• Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.
• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

What you need:

• Bachelor's Degree
• 3-6 years of experience in a Clinical Research environment
• Demonstrate good organizational skills, ability to prioritize tasks and to deal with competing priorities
• Good computer and Microsoft office knowledge
• Completes tasks independently on time and in an efficient manner.
• Ability to support other Site Specialists as needed.
• Demonstrate ability to deal with internal stakeholders.
• Demonstrate ability to identify study and site risks and properly document in tracking and reporting tools; support action planning with other study team stakeholders.

ロール概要

ICONのSOPやスポンサーSOP、関連する規制・ガイドライン、ICH/GCPの原則に基づき、治験実施施設の立ち上げに必要な規制文書やサイトレベルの重要文書の準備・手続き・進捗管理を支援します。
また、品質向上やプロセス改善の文化を大切にし、業務やツールの改善を通じてお客様の期待を超える価値を提供することに貢献していただきます。

主な業務内容

• Site Partnerや社内の主要ステークホルダーと協力し、スタディのパフォーマンスを最適化し、サイト立ち上げおよびプロジェクの成功を支援

• Site Partnerを支援し、中央/地方倫理審査委員会(EC/IRB)、各国当局への治験開始・維持申請パッケージの収集・確認・作成を実施

• 立ち上げに必要なCritical Document Package(CDP)および関連文書の取りまとめを行い、スポンサーおよび治験責任医師の義務を遵守できるようサポート

• CDPのチェックリストに沿って正確かつ完全な書類整備と、トラッキングツールのタイムリーな更新を実施

• 立ち上げ関連文書の翻訳対応のコーディネートを支援

• 施設から収集した文書や立ち上げに関する進捗を正確かつ迅速に管理ツールへ入力し、立ち上げ要件に沿ったタスク実行を管理

• サイト立ち上げ計画を正確に予測し、ICONのシステムに反映、計画達成に向けたフォローアップ

• スタディチームとのレビュー会議に参加し、リスク特定や対応策の計画を支援

• 治験マスターファイル(TMF)への文書提出における正確性・タイムリーな完了を担保し、メンテナンス移管前に品質確認(QC)を実施

応募要件

• 学士号以上

• 臨床開発分野で3~6年の経験

• 優れた組織力、タスクの優先順位付けスキル

• Microsoft OfficeなどのITスキル

• 自立して効率的に業務を遂行できる方

• 必要に応じて他のSite Specialistをサポートできる方

• 社内ステークホルダーと円滑に連携できるコミュニケーション力

• スタディおよびサイトのリスクを特定し、追跡ツール・報告ツールで適切に記録、他のチームと連携してアクションプランを策定できる方

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, 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 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

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