Osaka, JPN
6 days ago
Site Selection Specialist
Site Selection Specialist -Japan 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. At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. **Role** **&** **Responsibilities** Site Selection Specialist(サイトセレクション・スペシャリスト)は、治験を実施する医療機関・施設(治験実施医療機関)の調査を専門的に担当する役割です。臨床試験を成功させるためには、適切な施設・治験責任医師を選ぶことが非常に重要であるため、このポジションは開発初期の段階で大きな責任を担います。 主な業務内容 ・治験対象疾患の患者数や診療実績、過去の治験実績を調査 ・医療機関や治験責任医師に対し、治験実施の可能性を確認(質問票・電話・訪問など) ・競合治験や施設のリソース状況を把握 ・ Site Selection Leadと連携し、データベース・地域情報・インターネットなどを活用して候補施設を特定し、データ登録・管理を実施 ・担当エリア(国・地域・治療領域)で医師や施設との関係を築き、フィージビリティ調査や参加打診を行う ・ICON内のリーダー、責任者と協力し、施設リストの確認や国ごとの医療水準・施設特性の情報を収集・活用 ・収集した情報をシステムに正確に記録・更新し、知見を蓄積 ・ 機密保持を徹底し、必要に応じて秘密保持契約を締結 ・ データに不備があれば医療機関に確認し、正確で完全なデータを整備 ・ 各国の医療体制や標準治療を理解し、最適な施設選定につなげる **Requirements** 必須条件: ・Study Start-up、CRA、IHCRA、等にて目安2~3年程度のご経験をお持ちの方 ・業務に支障のない英語スキル(ビジネス英会話、英文読解、英文作成等が可能であり上長への英語でのReportingが可能) 歓迎(WANT): ・ 医療機関・施設との折衝経験があり、立ち上げ等に携わったご経験のある方 **Role Summary:** The Site Selection Specialist will contact and build relationships with study investigators/sites and networks in assigned areas for the conduct of feasibility and potential study participation. **Responsibilities:** + Work with the Site Selection Lead to ensure knowledge of the goals, scope and requirements of the project (e.g. number of sites required/country, number of positive responses required etc.) and ensure that high quality results are delivered. + Identify study investigators/ sites for potential study participation, both from the database and other potential sources such as local intelligence/internet etc. Ensure all newly identified sites are data based appropriately, checked for quality status and are fully processed. + To contact and build relationships with study investigators/ sites and networks in assigned areas (e.g. region(s), countries I countries or therapeutic area) for the conduct of feasibility and potential study participation. + To perform phone selection visits, if required. + To liaise with country managers to gather country specific evidence to support Site Selection, e.g. site list review, country specific profile of sites, standard of care. + To ensure that all data collected, in the conduct of Site Selection or site related country feasibility, is fully documented and kept up to date in relevant systems to build knowledge and intelligence. + To ensure appropriate procedures are followed, whether Sponsor specific or according to ICON SOPs, Site Selection RACI. + Ensure appropriate follow up with sites on any inconsistencies in data provided for analysis and to chase outstanding feasibility data to ensure a complete data set. + To contact investigators, local ICON employees and collect data to support country choice in the conduct of feasibility assessments. + To become a country expert on the investigator profile, healthcare setting, standard of care to ensure the best sites are approached for projects. + To liaise cross-functionally with other departments such as Study Start Up, CRA management to get local intelligence on sites and support local data collection. + Be an expert on how to interact with sites and obtain relevant information to support Site Selection. + Use knowledge and experience to build efficiency in the process and consistently deliver high quality investigators, sites, and other data to the Functional Lead for your projects. + Ensure debarred Investigators are not included in feasibilities or for study participation. + Ensure relevant parties, such as Site Selection lead, Feasibility Manager or Project Manager are aware of any Audit or Regulatory findings that may influence reasons for site selection. + Ensure confidentiality is maintained or appropriate confidentiality agreements are in place prior to study discussions. + Ensure all investigator feedback and status of contact with the site is tracked and data based appropriately, including reasons for site selection /de-selection. + Support other team members, e.g. seconded CRAs, on how to get the best information from sites, act as a trainer and mentor to new staff within the group. + Identify high performing sites and develop relationships with them as a single point of contact during site selection and ensure that key data collected from/related to these sites are maintained in ICON's systems. + Deliver high quality standards and strive for excellence, act in a proactive, flexible and responsive manner to both internal and external customer needs. + Establish good relationships internally and externally. + To undertake other reasonably related duties as may be assigned from time to time. + Recognize, exemplify and adhere to ICON's value, which centers around our commitment to People, Clients and Performance. + To embrace and contribute to our culture of process improvement with a focus on accelerating concept to cure. + Travel (approximately 10%) domestic and/or international, as required. + Responsible for implementing the project-specific Site Selection strategy at the country level. **What you need:** + Bachelor's Degree + 0-3 years of experience in a Clinical Research environment + Good communication skills + Good judgment and decision making + Proficient computer knowledge + Proficiency in English language is mandatory Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and 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 through the form below. **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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations) 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 (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
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