Clinical Research Regulatory Specialist II (IRB & Compliance)

Orlando Health, Inc.; Orlando (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

Orlando Health Cancer Institute in Orlando, FL, part of Orlando Health, is seeking a Clinical Research Regulatory Coordinator II to independently manage regulatory documentation for routine to moderately complex oncology trials.

You will submit local and central IRB materials, maintain inspection-ready files, and serve as a regulatory resource across study teams. A bachelor’s degree and 2 years of experience are preferred; certification is encouraged.

Qualifications

• Bachelor’s degree required in healthcare, life sciences, regulatory, or related field.
• Associate’s degree with two years of directly related work experience may substitute for the bachelor's degree requirement.
• High school diploma or equivalent with four years of directly related work experience may substitute for the bachelor's degree requirement.
• Two years of direct clinical research regulatory experience required.
• Experience with local and central IRB submissions, regulatory documentation, and study lifecycle management preferred.

Responsibilities

• Prepare and submit IRB materials for new studies and amendments.
• Maintain inspection-ready regulatory binders and electronic records.
• Act as liaison among investigators, sponsors, IRBs, and review committees.
• Respond to queries and escalate complex issues with compliant resolutions.
• Prepare studies for monitoring visits and assist with audits.
• Guide staff on routine submissions and study documentation.

Skills

Clinical research regulatoryExperience

IRB submissions

Regulatory documentation

Quality assurance

Study lifecycle management

Education

Bachelor’s degree in healthcare, life sciences, regulatory, or related field

Associate’s degree with 2 years related experience substitution

High school diploma with 4 years related experience substitution

Tools

IRB platforms

CTMS

e-regulatory systems

Job description

Orlando Health Cancer Institute in Orlando, FL, part of Orlando Health, is seeking a Clinical Research Regulatory Coordinator II to independently manage regulatory documentation for routine to moderately complex oncology trials.

You will submit local and central IRB materials, maintain inspection-ready files, and serve as a regulatory resource across study teams. A bachelor’s degree and 2 years of experience are preferred; certification is encouraged.