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18 часов назад

Regulatory Coordinator (Clinical Cancer Research)

21 - 53$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
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 Coordinator (Clinical Cancer Research) (IRB/GCP): Coordinating regulatory requirements for clinical research studies, including protocol start-up, submissions, amendments, safety reporting, and compliance tracking with an accent on IRB documentation, FDA regulations, HIPAA confidentiality, and ICH/GCP guidelines. Focus on maintaining accurate study records, coordinating regulatory communications, and resolving submission and reporting requirements across research teams, sponsors, and regulatory organizations.

Location: Tufts Medical Center, United States; onsite role

Pay range: $21.53–$26.91 per hour

Company

hirify.global provides clinical care and supports clinical cancer research through the Neely Center for Cancer Clinical Research.

What you will do

  • Track and manage new clinical research protocols through study start-up and monitor progress against established benchmarks.
  • Prepare, submit, and maintain IRB and SRC documentation, including protocol amendments, consent changes, safety reports, deviations, and violations.
  • Review protocols and regulatory materials, maintain study files, and implement improvements to support compliance.
  • Coordinate regulatory submissions and communications with research coordinators, project managers, principal investigators, sponsors, agencies, and external research organizations.
  • Maintain systematic records and ensure required regulatory reporting is completed accurately and on time.
  • Protect patient confidentiality and secure study information in accordance with HIPAA requirements.

Requirements

  • Bachelor’s degree.
  • Strong organizational, data collection, and analysis skills with meticulous attention to detail.
  • Excellent computer, communication, interpersonal, and prioritization skills.
  • Working knowledge of current research regulations, regulatory guidance, and local policies.
  • Ability to follow FDA Good Clinical Practice and ICH/GCP guidelines.

Nice to have

  • At least one year of research-related experience.
  • CITI Human Research Protection Certification.
  • Previous regulatory or IRB submission experience.

Culture & Benefits

  • Comprehensive Total Rewards package supporting health, financial security, and career growth.
  • Compensation is determined based on experience, certifications, education, skills, and internal equity.
  • Collaborative work with clinical research personnel, faculty, sponsors, regulatory agencies, and external institutions.

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