Orlando Health · 5 hours ago
Clinical Research Regulatory Coordinator II - Digestive Health Institute
Orlando, FL
Full-time
Onsite
Entry, Mid Level
2+ years expOrlando Health is an international destination for care specializing in digestive health. The Clinical Research Regulatory Coordinator II is responsible for preparing and submitting research documentation to regulatory authorities, maintaining regulatory binders, and providing guidance to less experienced staff while ensuring compliance with regulatory requirements.
Health CareHospitalMedicalNon Profit
Responsibilities
Prepares and submits both local and central Institutional Review Board (IRB) documents for new trials, continuing reviews, amendments, safety events, and protocol deviations independently
Maintains both paper and electronic regulatory binders for all clinical trials
Prepares study documentation for long-term storage
Prepares for monitoring visits and audits of regulatory records
Provide guidance to less experienced staff
Familiar with regulatory requirements for industry, national and investigator-initiated trials
Liaison between the Principal Investigator, FDA, pharmaceutical sponsors, consortium partners, other funding entities, and the IRB and ancillary review committees
Responds and resolves queries from the regulatory governing bodies
Collaborates with other Hospital departments acting as a research regulatory resource
Assists with quality assurance activities for the department
May coordinate and assist with external audits and monitor visits
Respects diversity by building respectful relationships with all team members, investigators, sponsors, and regulatory authorities
Assesses clinical trial needs and develops/revises priorities based on needs and responses. Evaluates trial progress toward and reports as applicable
Demonstrates competency in regulatory affairs as defined by department-specific requisite skills
Prioritizes clinical trial needs based on trial status, participant, and departmental needs
Practices effective problem identification and resolution
Demonstrates awareness of legal issues
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
Attends team, staff and departmental meetings as required
Demonstrates expertise of computer software specific to department
Qualification
Required
Associates degree with four (4) years' experience in research OR
Bachelor's degree with two (2) years' experience in research
If no degree, experience may be substituted at a 2 for one ratio
Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP)
Benefits
Career-growing FREE education programs
Well-being services
Company
Orlando Health
Orlando Health is one of Florida's most comprehensive private, not-for-profit healthcare networks.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mildred Beam
SVP, Chief Legal Strategist
Mark Jones
Executive Vice President
Recent News
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2025-11-04
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