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20 дней назад

Regulatory and Site Start Up Specialist

Формат работы
remote (только Taiwan)
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
Taiwan
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Regulatory and Site Start Up Specialist (Clinical Research): Preparing and coordinating clinical trial submissions, essential documents, and site activation activities in Taiwan with an accent on regulatory compliance, ethics committee interactions, and study start-up timelines. Focus on maintaining critical-path data, coordinating translations and contracts, and ensuring audit readiness under local regulations and ICH-GCP.

Location: Remote, Taiwan

Company

hirify.global is a Clinical Research Organization supporting precision medicine studies, including rare disease and oncology trials, through clinical operations, medical expertise, biomarker solutions, and data analytics.

What you will do

  • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Coordinate responses and communications with regulatory authorities and ethics committees.
  • Track submissions, approvals, milestones, risks, and site activation readiness for assigned countries and sites.
  • Coordinate essential document collection, site review, IMP release requirements, informed consent customization, and document translations.
  • Collaborate with Clinical Operations, Project Management, Feasibility, Regulatory, Site Contracts, and assigned CRAs.
  • Maintain audit and inspection readiness and file documents in the relevant Trial Master File.

Requirements

  • Bachelor’s degree in life sciences or a related field, or RN qualification, or an equivalent combination of education, training, and experience.
  • At least 1 year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
  • Fluency in English required.
  • Strong communication, organization, prioritization, and deadline-management skills.
  • Experience with computerized information systems, spreadsheets, word processing, and email.
  • Ability to maintain knowledge of local clinical trial laws, regulations, and ICH-GCP principles.

Nice to have

  • Pharmacy qualification or pharmacist experience.
  • Experience with feasibility, contract negotiations, and Competent Authority, Ethics Committee, or IRB submissions.
  • Experience with milestone tracking tools and systems.
  • Advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Culture & Benefits

  • Remote work arrangement in Taiwan.
  • Opportunity to contribute to clinical research involving cancer therapies, rare diseases, and precision medicine.
  • Employee ideas and contributions are valued and supported.

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