You’ll need
Education
✓Bachelor's degree
Qualifications
✓2 years' experience
✓Deep working knowledge of FDA, OHRP, ICH GCP, and institutional regulatory requirements
Minimum 2 years of regulatory experience in oncology or complex therapeutic area clinical research preferred
Proven success preparing and submitting IND safety reports, protocol amendments, continuing reviews, and IRB submissions preferred
Familiarity with central IRBs, local IRBs, and multi site regulatory coordination preferred
Demonstrated ability to manage multiple studies simultaneously in a fast moving research environment preferred
Strong proficiency with clinical trial management systems (CTMS), eReg systems, and electronic IRB platforms preferred
Exceptional communication skills with investigators, sponsors, monitors, and cross functional oncology teams preferred
Ability to interpret complex regulatory guidance and provide clear, proactive recommendations to study teams preferred
Benefits
Medical, dental and visionRetirement planWellness and mental health resources
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About the role
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.
What you’ll do
Prepare, manage, and trackPrepare, manage, and track regulatory submissions for oncology clinical trials
Maintain essential documents andMaintain essential documents and ensure every study meets the highest ethical, safety, and compliance standards
Collaborate closely with investigatorsCollaborate closely with investigators, sponsors, and multidisciplinary oncology teams to keep trials moving forward
Serve as a trustedServe as a trusted resource for regulatory guidance across early‑phase, late‑phase, and disease‑specific cancer studies