49 минут назад
Site Activation Specialist (Clinical Research)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Site Activation Specialist (Clinical Research): Coordinating clinical trial site feasibility, activation, regulatory submissions, essential documentation, and study tracking across Romania with an accent on compliance, document accuracy, and milestone management. Focus on following up on regulatory, ethics, and contractual approvals, maintaining activation timelines, and coordinating investigative sites with clinical operations and project stakeholders.
Location: Bucharest, Romania (Hybrid)
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Act as the primary point of contact for investigative sites during feasibility and site activation.
- Coordinate site start-up and maintenance activities in line with regulations, SOPs, and project requirements.
- Prepare, review, and manage essential study documentation, including CDAs, feasibility questionnaires, regulatory submissions, ethics documentation, ICFs, and investigator pack materials.
- Track regulatory, ethics, and contractual submissions, approvals, timelines, databases, and activation milestones.
- Communicate document completion and activation progress to project teams and stakeholders.
- Collaborate with Site Activation Managers, Clinical Operations, Project Managers, investigative sites, and sponsors.
Requirements
- Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, Nursing, Biology, or a related field, or equivalent education and experience.
- 1–3 years of experience in clinical research, site activation, regulatory affairs, clinical operations, or a related healthcare area.
- Experience with site activation, regulatory submissions, clinical trial documentation, or site management.
- Strong organizational, prioritization, communication, and stakeholder management skills.
- Romanian: native proficiency required.
- English: advanced written and spoken proficiency required.
Culture & Benefits
- Hybrid working model.
- Opportunity to contribute to international clinical research projects.
- Professional development and career growth within a global organization.
- Collaborative and inclusive work environment.
- Competitive compensation and benefits package.
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