Clinical Research Regulatory Coordinator II - Orlando Health Cancer Institute

Orlando Health•Orlando, FL

About The Position

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. The coordinator maintains regulatory compliance throughout the study lifecycle and serves as a regulatory resource for study teams. This independent-contributor role manages a routine-to-moderately complex regulatory portfolio, uses judgment to resolve routine issues, and escalates complex or high-risk matters. It is part of a specialized clinical research regulatory career pathway requiring independent judgment and technical proficiency, with increasing responsibility for regulatory decision-making and study complexity. Orlando Health Cancer Institute is a multidisciplinary cancer program with six treatment sites and more than 10 practice locations. Its research program supports physician participation in research studies and clinical trials. The institute is part of the Orlando Health system of care. Orlando Health describes benefits that include career-growing free education programs and well-being services for employees and their families. Benefits begin on the first day, and flexibility is offered wherever possible.

Requirements

Bachelor’s degree in healthcare, life sciences, regulatory, or a related field; an associate’s degree plus two years of directly related work experience, or a high school diploma or equivalent plus four years of directly related work experience, may substitute for the bachelor’s degree requirement.
Two years of direct clinical research regulatory experience.
Must be eligible for SOCRA CCRP, ACRP CCRC/ACRP-CP, or PRIM&R CIP certification.

Nice To Haves

Additional specialty training in quality, project management, oncology research, or regulatory affairs.
Experience with local and central IRB submissions, regulatory documentation, and study lifecycle management.
Experience serving as a regulatory resource to study teams and independently managing routine-to-moderately complex regulatory submissions.
Active SOCRA CCRP, ACRP CCRC/ACRP-CP, or PRIM&R CIP certification.

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, and 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.
Perform other duties as assigned.
Attend team, staff, departmental, sponsor, and/or cross-functional meetings as required.
Maintain proficiency with clinical research systems, IRB platforms, CTMS/e-regulatory systems, document management tools, and department-specific software.
Maintain reasonably regular, punctual attendance consistent with Orlando Health policies and applicable standards.
Maintain compliance with all Orlando Health policies and procedures.