FSA-Site Specialist Ⅰ, Site Specialist II and Senior Site Specialist
- Osaka, Tokyo
- Study Start Up
- ICON Full Service & Corporate Support
- Office Based
Talent Acquisition Business Partner
- Full Service Division
About the role
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トの成功を支援
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, 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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
What you will be doing:As a Contract Negotiator, you will play an integral role in ensuring physicians at our research sites are prepared to initiate clinical trials of investigational pharmaceutical
Reference
JR128998
Expiry date
01/01/0001
Author
Diego ToniniAuthor
Diego ToniniSalary
Location
Brazil
Department
Study Start Up
Location
Brazil
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Study Start Up Associate/ Site Activation Partner you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative
Reference
2025-120467
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
US, Salt Lake City (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Salt Lake City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Recruitment Representative to join our diverse and dynamic team at ICON at our Salt Lake City UT site. Location: On-Site Salt Lake City UTJob Type: Full Time
Reference
JR131004
Expiry date
01/01/0001
Author
Kris CostelloAuthor
Kris CostelloSalary
Location
Poland, Warsaw
Location
Sofia
Prague
Dublin
Riga
Warsaw
Lisbon
Belgrade
Bratislava
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Accountable for driving and accelerating the activation of global investigative sites in line with, or ahead of, the study's contractual timelines, within budgeted resources, with quality output, and
Reference
JR132104
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Turkey, Ankara
Location
Ankara
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Role Summary:Accountable for the expert level independent and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s
Reference
JR129137
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
UK, Swansea
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Swansea
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
The Senior Study Support Assistant is responsible for assigned project site start-up and qualification activities per study specific requirements. Additionally, the Senior Study Support Assistant will
Reference
JR130731
Expiry date
01/01/0001
Author
James SmithAuthor
James Smith