Clinical Research Regulatory Coord II - Orlando Health Cancer Institute

Position Summary

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. Work location: 3090 Caruso Ct. Suite 20 Orlando FL Work schedule: 8:00 am - 4:00 pm

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).