5 часов назад
Protocol Navigator (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
Protocol Navigator (Clinical Research): Supporting NIH Clinical Center investigators with clinical research protocols, informed consent forms, IRB submissions, and regulatory documentation with an accent on document consistency, committee submissions, and regulatory coordination. Focus on maintaining regulatory binders, preparing protocol amendments and continuing reviews, coordinating with IRB and sponsors, and supporting FDA-related interactions.
Location: Onsite at 9000 Rockville Pike, Bethesda, Maryland, United States
Company
Services and Federal Solutions provides support services to the National Institutes of Health Clinical Center.
What you will do
- Support Principal Investigators and research teams in developing clinical research protocols, informed consent forms, and related study documents.
- Review, revise, format, and maintain consistency across protocols, consent forms, and regulatory sections.
- Prepare and submit materials for IRB, Ancillary Review, continuing review, protocol amendments, reliance agreements, and scientific reviews.
- Manage regulatory forms and documentation, including Resource Assessment, travel reimbursement, ethics clearance, and radiation safety submissions when applicable.
- Maintain regulatory binders, update Protocol View, respond to protocol service requests, and support monitoring visits.
- Act as a liaison and primary point of contact among IRB committees, sponsors, research sites, and research teams.
Requirements
- Bachelor of Science degree in a related field.
- Strong English reading, writing, and speaking skills required to communicate effectively with all parties.
- Computer literacy and the ability to format and manage study documentation.
- Initiative, interpersonal skills, and social sensitivity when working with patients from diverse backgrounds.
- Onsite availability in Bethesda, Maryland required.
Culture & Benefits
- Robust employee benefits program.
- Management engagement and quality leadership.
- Team-oriented work environment with recognition for performance.
- Opportunities for promotion and professional growth.
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