Regulatory Coordinator - Cancer Center

Regulatory Coordinator – Cancer Center

Department: SOM KC Cancer Center Clinical Trials / Regulatory Affairs

Position Title:

Regulatory Coordinator – Cancer Center

Job Family Group:
Professional Staff

The Regulatory Coordinator is responsible for performing study‑specific regulatory and safety reporting across multiple studies. This involves ensuring compliance with applicable federal, state, or international requirements, and the policies of The University of Kansas Medical Center. The Coordinator is the primary contact for study start‑up activities—including IRB/Ancillary committee submissions—and maintains regulatory records throughout the life of an assigned protocol.

KU Cancer Center is the region’s only National Cancer Institute–designated comprehensive cancer center, providing patients access to cutting‑edge clinical trials and world‑class research.

• Prepare and submit all regulatory documents, including study documents to the Institutional Review Board.
• Collaborate with team members to ensure regulatory documents are completed accurately.
• Maintain trial master file and/or regulatory binder.
• Assist study monitors during routine monitor visits or audits.
• Maintain regulatory records throughout the life of the trial.
• Update protocol‑specific systems with complete and accurate protocol and study information.
• Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.

• 4 years of relevant work experience (education may substitute on a year‑for‑year basis).
• Experience with regulations governing clinical research (CFR, GCP, HIPAA).
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience with medical terminology and concepts.
• Experience working with multidisciplinary teams.

• Education:
  
  Bachelor’s degree in a relevant field of study.

• Certified Clinical Research Coordinator (CCRC) or eligible certification.
• Certified Clinical Research Professional (CCRP) or eligible certification.
• Collaborative Institutional Training Initiative (CITI) training certification or other research certification.

• Computer skills.
• Interpersonal skills.
• Multitasking skills.
• Communication skills.
• Analytical and problem‑solving skills.

• Resume/CV
• Cover Letter

Full‑time, regular hourly position.

Pay range: $26.13 – $39.20 per hour (minimum $26.13, midpoint $32.67, maximum $39.20).

Benefits include health, dental, and vision insurance starting day one; employer‑paid life, long‑term disability; paid time off (vacation, sick, holidays, bereavement, jury duty, military service, and parental leave); and a retirement program with employer contributions.

To learn more and apply online, visit the University of Kansas Medical Center careers site (search for position number JR009441) or the Workday listing.

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.