Research Regulatory Coordinator

St.-Luke; Boise (ID); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

On-site massages

Employee Assistance Program

Wellness tools

Career development

Job summary

St. Luke’s invites applications for a Research Regulatory Coordinator to navigate FDA, IRB, and ICH GCP requirements in oncology trials. The role focuses on regulatory submissions and documentation to advance breakthrough cancer care.

Join a mission-driven team at St. Luke’s that values accuracy, collaboration, and growth, with comprehensive benefits and steady professional development.

Qualifications

• 2+ years of regulatory experience in oncology or complex therapeutic area clinical research
• Experience with FDA/ICH GCP and IRB submissions is strongly preferred
• Ability to manage multiple studies and coordinate regulatory activities across sites

Responsibilities

• Prepare, manage, and track regulatory submissions for oncology clinical trials
• Maintain essential documents and ensure every study meets high ethical, safety, and compliance standards
• Collaborate with investigators, sponsors, and multidisciplinary oncology teams to keep trials moving forward
• Serve as a trusted regulatory guidance resource across early- and late-phase and disease-specific cancer studies

Skills

Regulatory experience

Oncology

FDA

ICH GCP

IRB submissions

IND safety reports

Regulatory submissions

Multisite coordination

CTMS

eReg systems

IRB platforms

Communication skills

Regulatory guidance

Tools

CTMS

eReg systems

Electronic IRB platforms

Job description

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:

• 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

What's In It For You

At St. Luke’s, caring for people in the communities we serve is our mission – and this includes our own SLHS team. We offer a robust benefits package to support our teams both professionally and personally. In addition to a competitive salary and retirement plans, we ensure our team feels supported in their benefits beyond the typical medical, dental, and vision offerings. We care about you and have fantastic financial and physical wellness options, such as: on-site massages, on-site counseling via our Employee Assistance Program, access to the Personify Health Wellness tool, as well as other formal training and career development offerings to ensure you are meeting your career goals.

St. Luke’s is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.

*Please note: this posting is not reflective of all job duties and responsibilities and is intended to provide an overview to job seekers.