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Position Summary:

As a top cancer care provider in Florida, Orlando Health Cancer Institute is a comprehensive, multidisciplinary cancer program consisting of six treatment sites and more than 10 practice locations that serve the region’s adult oncology needs. Specializing in more than 200 types of cancer, an expert team of medical professionals provides personalized care with the most state-of-the-art technologies, such as advanced radiation and proton therapies, and bone marrow transplant and cellular therapy. Through a robust research program, the institute also supports physician involvement in numerous research studies and clinical trials that give patients access to innovative diagnosis, treatment and symptom management options. In addition to being accredited by the Commission on Cancer, a program of the American College of Surgeons, Orlando Health Cancer Institute has earned accreditations and certifications in several areas — including medical oncology and hematology/oncology, radiation oncology, cellular therapy, rectal cancer, and breast care — from the respective accrediting organizations, and recently was named in the 2023 Becker's Hospital Review “60 Hospitals and Health Systems with Great Oncology Programs” list.

Orlando Health Cancer Institute is part of the Orlando Health system of care, which includes 24 award-winning hospitals and ERs, 9 specialty institutes, 14 urgent care centers, 100+ primary care practices and more than 60 outpatient facilities that span Florida’s east to west coasts and beyond. Collectively, we honor our 100-year legacy by providing care for more than 142,000 inpatient and 3.9 million outpatient visits each year.

Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible so that you can be present for your passions. “Orlando Health Is Your Best Place to Work” is not just something we say, it’s our promise to you.

A Brief Overview

The Clinical Research Regulatory Coordinator II independently prepares and submits regulatory documentation for routine-to-moderately complex clinical research studies to local and central IRBs and other regulatory authorities. Maintains regulatory compliance throughout the study lifecycle and serves as a regulatory resource for study teams. Independent contributor responsible for routine-to-moderately complex regulatory portfolio. Uses judgment to resolve routine issues and escalates complex or high-risk matters. This role represents an independent contributor level within a specialized clinical research regulatory career pathway, with increasing responsibility for regulatory decision-making and study complexity. These roles support specialized clinical research regulatory functions requiring independent judgment, technical proficiency, and the ability to manage increasing levels of study complexity across the clinical research lifecycle.

Responsibilities:

• Independently prepare and submit local and central IRB materials for new studies, amendments, continuing reviews, safety events, protocol deviations, consent revisions, and study closures
• Maintain complete, inspection-ready regulatory binders and electronic records for assigned studies
• Serve as liaison among investigators, sponsors, consortium partners, funding entities, IRBs, CORO, and ancillary review committees
• Respond to IRB, sponsor, and regulatory queries; identify issues requiring escalation and recommend compliant resolution pathways
• Prepare assigned studies for monitoring visits and audits; assist with corrective actions and documentation follow-up
• Guide less experienced staff on routine submissions, binder standards, tracking requirements, and study documentation expectations
• Apply regulatory requirements for industry-sponsored, cooperative group/national, and investigator-initiated trials
• Participate in departmental quality assurance, process improvement, and standard work initiatives
• Performs other duties as assigned
• Attends team, staff, departmental, sponsor, and/or cross-functional meetings as required
• Maintains proficiency with clinical research systems, IRB platforms, CTMS/e-regulatory systems, document management tools, and department specific software
• Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards
• Maintains compliance with all Orlando Health policies and procedures

Qualifications

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

Associate’s degree and two (2) years of directly related work experience (in addition to the requirements listed in the Experience section) may substitute for the bachelor's degree requirement.

High school diploma or equivalent and four (4) years of directly related work experience (in addition to the requirements listed in the Experience section) may substitute for the bachelor's degree requirement.

Additional specialty training in quality, project management, oncology research, or regulatory affairs preferred.

Two (2) years of direct clinical research regulatory experience required.

Experience with local and central IRB submissions, regulatory documentation, and study lifecycle management preferred.

Experience serving as a regulatory resource to study teams and independently managing routine-to-moderately complex regulatory submissions preferred.

Must be eligible for SOCRA CCRP, ACRP CCRC/ACRP-CP, or PRIM&R CIP; active certification is preferred.