Oncology Clinical Trials Regulatory Manager

City of Hope; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

City of Hope, a national leader in cancer research and care, seeks a Project Manager to join the CTO regulatory team. You will assist investigators with regulatory submissions to IRB, DSMC, PRMC, WIRB and CIRB, and coordinate study activations to ensure timeliness.

The PM will liaise with sponsors, external IRBs, and study teams, overseeing ongoing regulatory management and budget support using iRIS and OnCore systems. A bachelor’s degree and 2+ years in oncology regulatory trials are required.

Qualifications

• Bachelor’s degree required.
• Minimum of 2 years of experience related to regulatory management and oncology clinical trials.
• Experience with regulatory oversight and IRB/DSMC/PRMC/WIRB/CIRB submissions.

Responsibilities

• Coordinate new clinical trial submissions, including IRB approvals and activation requirements.
• Maintain regulatory documentation meeting institutional, state, federal, sponsor, FDA, and NCI requirements.
• Collaborate with investigators, sponsors, IRB, and internal stakeholders to ensure timely approvals and deliverables.
• Mentor regulatory coordinators and assist with onboarding staff on trial policies and data entry.
• Lead team meetings, track deadlines and regulatory status, support MCA/OnCore activities.

Education

Bachelor’s degree

Tools

OnCore

iRIS

IRB procedures

Budget development

Job description

City of Hope, a national leader in cancer research and care, seeks a Project Manager to join the CTO regulatory team. You will assist investigators with regulatory submissions to IRB, DSMC, PRMC, WIRB and CIRB, and coordinate study activations to ensure timeliness.

The PM will liaise with sponsors, external IRBs, and study teams, overseeing ongoing regulatory management and budget support using iRIS and OnCore systems. A bachelor’s degree and 2+ years in oncology regulatory trials are required.