IRB Coordinator II

2 weeks ago

Orlando, United States Orlando Health Full time

Position Summary:

The IRB Coordinator II is responsible for the review and approval process of proposed documentation for research activities involving human subjects to protect their safety, rights, and welfare. This documentation includes but is not limited to regulatory submissions from all research departments, educational materials, safety and deviation reports, and study forms. May prepare and maintain additional documentation that would be reported to regulating authorities, such as the Federal Drug Administration and Institutional Biosafety Committees and Radiation Safety Committees. Leads the review of study specific documentation and process of a moderate nature.

Responsibilities:

Prepares the reviews of protocols and assists in determining whether they are within the regulatory guidelines of Orlando Health, National Institute of Health (NIH), Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and needs and requirements of study sponsors.
Maintains reviews of research submissions received from researchers from the Orlando Health hospital system using the IRBNet system.
Prepares study documentation for long-term storage.
Prepares for internal/external 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, IRB members, corporate research, funding entities, and ancillary review committees
Responds and resolves queries from all research departments of Orlando Health.
Respects diversity by building respectful relationships with all team members, investigators, sponsors, and regulatory authorities
Assesses and evaluates trial progress for study renewals, closures, deviations, and other events. Issues queries requesting additional information and revisions to IRB submissions; reviews and evaluate responses to ensure the requests for changes have been satisfied.
Reports as applicable. Demonstrates competency in regulatory knowledge as defined by job-specific requisite skills.
Practices effective problem identification and resolution.
Demonstrates awareness of legal or regulatory issues
Serves as a preceptor, mentor for staff and/or departmental educator presenting IRB informational sessions to provide education
regarding submitting research projects to the Orlando Health IRBs.
Functions as a departmental advocate.
Assists with quality assurance activities for IRB board and in research departments.
Serves as a role model for staff and supports Orlando Health and departmental goals and strategies
Responsible for the preparation of submissions for review by the IRB Pre-Review Committee and/or final review by the
Institutional Review Board (IRB) Manager and/or IRB Chairpersons.
Responsible for activities related to the monthly Orlando Health IRB meetings including, but not limited to, creating
meeting agenda, recording meeting minutes, and issuing IRB determination letters.
Coordinates submissions expanded access treatment uses (e.g., Single Patient IND, compassionate uses, etc.).
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:

Education/Training
Bachelors degree required.


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

Experience
Four (4) years of IRB, clinical research, or other directly related experience.

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