Trial Clinical Research Regulatory Coordinator - Orlando Health Cancer Institute

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 providespersonalized 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 supportsphysician 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 wasnamed 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.
Position Summary
The Clinical Research Regulatory Coordinator II prepares and submits multiple levels of research documentation to federal, state, and local regulatory authorities. This documentation includes but is not limited to IRB submissions (local and central IRBs), educational
materials, safety and deviation reports, and study forms. May prepare and maintain additional submissions to regulating authorities, such as the Federal Drug Administration and Institutional Biosafety Committees and Radiation Safety Committees. Leads the
implementation of study specific regulatory processes of a moderate to complex nature.

• Clinical trial experience is preferred**
  

Responsibilities
Essential Functions

• 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.
  

Other Related Functions

• Attends team, staff and departmental meetings as required.
• Demonstrates expertise of computer software specific to department.
  

Qualifications
Education/Training
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.
Licensure/Certification
Must be eligible for Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical
Research Coordinator (ACRP).