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Research Regulatory Coordinator
Research Regulatory Coordinator — Advance Breakthroughs in Cancer Care
If you’re detail‑driven, compassionate, and motivated by work that directly impacts patients facing cancer, this role places you at the center of oncology research that saves lives. We’re seeking a Research Regulatory Coordinator who brings both precision and heart to the mission—someone who can navigate complex regulatory requirements while supporting teams dedicated to improving outcomes for patients and families affected by cancer.
What You’ll Do
- Prepare, manage, and track regulatory submissions for oncology clinical trials
- Maintain essential documents and ensure every study meets the highest ethical, safety, and compliance standards
- Collaborate closely with investigators, sponsors, and multidisciplinary oncology teams to keep trials moving forward
- Serve as a trusted resource for regulatory guidance across early‑phase, late‑phase, and disease‑specific cancer studies
Why This Role Matters
Oncology research is uniquely urgent and deeply human. Behind every new therapy, every extended life, and every moment of hope is a team ensuring the research is safe, ethical, and meticulously documented. Your work helps bring cutting‑edge treatments, from immunotherapies to targeted agents, to the patients who need them most.
Why You’ll Love Working With Us
- A mission‑driven environment focused on transforming cancer care
- A collaborative, supportive research team that values your expertise
- Opportunities to grow your career in a rapidly evolving oncology research landscape
- Competitive compensation and comprehensive benefits
Minimum Qualifications:
- Education: Bachelor's degree
- Experience: 2 years' experience
Preferred Qualifications:
- Minimum 2 years of regulatory experience in oncology or complex therapeutic area clinical research
- Deep working knowledge of FDA, OHRP, ICH GCP, and institutional regulatory requirements
- Proven success preparing and submitting IND safety reports, protocol amendments, continuing reviews, and IRB submissions
- Familiarity with central IRBs, local IRBs, and multi site regulatory coordination
- Demonstrated ability to manage multiple studies simultaneously in a fast moving research environment
- Strong proficiency with clinical trial management systems (CTMS), eReg systems, and electronic IRB platforms
- Exceptional communication skills with investigators, sponsors, monitors, and cross functional oncology teams
- Ability to interpret complex regulatory guidance and provide clear, proactive recommendations to study teams
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