Research Regulatory Coordinator

St. Luke's Health System•Boise, ID

5h•Onsite

About The Position

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. 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.

Requirements

Bachelor's degree
2 years' experience

Nice To Haves

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

Responsibilities

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