18 часов назад
Regulatory Coordinator (Clinical Cancer Research)
21 - 53$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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