9 часов назад
Regulatory & Start-Up Specialist 1
47 700 - 123 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory & Start-Up Specialist 1 (Clinical Research): Supporting country-level site activation and regulatory activities for clinical studies with an accent on document preparation, site coordination, and compliance with applicable regulations and SOPs. Focus on tracking regulatory and ethics approvals, maintaining study systems, performing document quality control, and coordinating timelines across investigative sites and project teams.
Location: Durham, North Carolina, United States of America
Salary: $47,700–$123,000 annualized base pay
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Act as the single point of contact for investigative sites, Site Activation Managers, project management, and supporting departments.
- Perform country-level start-up and site activation activities in accordance with regulations, SOPs, work instructions, project requirements, and timelines.
- Prepare, distribute, review, and quality-check regulatory and contractual documents for clinical study sites.
- Track regulatory, ethics, informed consent, and Investigator Pack documents through approval and execution.
- Maintain study systems, databases, tracking tools, project information, and site performance metrics.
- Support project planning, timeline management, monitoring measures, contingency planning, and sponsor communication.
Requirements
- At least 1 year of clinical research experience, or an equivalent combination of education, training, and experience.
- Ability to work with regulatory documents, site activation processes, and clinical study timelines.
- Ability to follow applicable regulations, standard operating procedures, and work instructions.
- Strong document review, tracking, coordination, and quality-control skills.
Culture & Benefits
- Full-time employment.
- Health and welfare benefits may be provided.
- Incentive plans, bonuses, and other compensation may be available depending on the position.
- Equal opportunity employment practices.
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