GOVERNMENT OPERATIONS CONSULTANT III - 64005236

State of Florida • TALLAHASSEE, FL

6d • $49,766 - $65,000 • Onsite

About The Position

This position provides administrative support to the Department of Health (DOH) Institutional Review Board (IRB), as the IRB Coordinator. The role involves applying institutional policies and procedures to ensure compliance with OHRP and FDA regulations. The IRB Coordinator will provide oversight of the DOH IRB committee(s) and related education of committee members to ensure they are knowledgeable about regulations, policies, expectations, and accreditation standards relevant to their roles. The position also involves preparing materials for review and approval by IRB Chairs, Co-Chairs, and IRB committee members, and planning, scheduling, and facilitating IRB meetings, including drafting agendas, meeting minutes, and follow-up communications. The role requires developing and maintaining operational procedures for efficiently processing applications, assigning applications to reviewers, conducting meetings, and notifying applicants of IRB determinations. The IRB Coordinator will review and prepare all types of submissions, including initial applications, continuing reviews, amendments, and reports of problems or non-compliance. This includes independently reviewing IRB applications for completeness and compliance with applicable state and federal laws and regulations pertaining to human subject research and DOH IRB policies. The position also involves consulting with investigators to provide guidance for improving or modifying applications, including informed consent documents, and utilizing the IRB Manager system for maintaining all IRB documents. The IRB Coordinator will monitor IRB Manager performance, advise investigators on applicable laws and regulations, and assist with the processing of research protocols. Additionally, the role involves providing guidance on new studies, continuing reviews, and modifications, assisting with improvements to the program website and IRB applications, and reviewing and updating DOH program policies. The incumbent must maintain active knowledge of evolving laws, regulations, policies, and ethical norms applicable to human research activities through continuous professional development. The position also provides oversight of the Association for the Accreditation of Human Research Protection Program (AAHRPP) efforts of the DOH and assists as a subject matter expert on research programs and projects as needed. Other duties as assigned.

Requirements

• Proficient experience in Microsoft Office Suite.
• Critical thinking, problem solving, emotional intelligence.
• Ownership and commitment, business acumen, relationship management, customer centricity, and risk management.
• Understanding of methods of data collection and analysis; basic management principles and practices.
• Ability to work independently, determine work priorities and ensure proper completion of work assignments.
• Ability to communicate effectively both verbally and in writing; assess budgetary needs; formulate policies and procedures; understand and apply applicable rules, regulations, policies and procedures relating to the program.
• Ability to organize data into logical format for presentation in reports, documents and other written materials; collect, evaluate and analyze data to develop alternative recommendations, solve problems, document work flow and other activities relating to the improvement of operational and management practices.
• Ability to conduct fact finding research; solve problems and make decisions.
• Ability to learn and communicate effectively, orally and in writing, in English.

Nice To Haves

• Current Collaborative Institutional Training Initiative (CITI) or similar program training.
• Proficient experience with the IRB Manager system.

Responsibilities

• Provide administrative support to the Department of Health (DOH) Institutional Review Board (IRB), as the IRB Coordinator, applying institutional policies and procedures to ensure compliance with OHRP and FDA regulations.
• Provide oversight of the DOH IRB committee(s) and related education of committee members to ensure members are knowledgeable about regulations, policies, expectations, and accreditation standards relevant to their roles.
• Prepares materials for review and approval by IRB Chairs, Co-Chairs, and IRB committee members.
• Plans for, schedules, and facilitates IRB meetings including drafting of the agenda, meeting minutes, and follow-up communications.
• Develops and maintains operational procedures for efficiently processing applications, assigning applications to reviewers, conducting meetings, and notifying applicants of IRB determinations.
• Reviews and prepares all types of submissions including initial applications requiring review by the full board or review using the expedited procedure, continuing reviews, amendments and reports of problems or non-compliance.
• Independently reviews IRB applications for completeness and compliance with applicable state and federal laws and regulations pertaining to human subject research and DOH IRB policies.
• Consults with investigators to provide guidance for improving or modifying applications, including informed consent documents.
• Utilizes IRB Manager system for maintaining all lRB documents for research studies. This includes version control, intake, monitoring and archiving.
• Monitors IRB Manager performance and reduces errors.
• Advises investigators of applicable state and federal laws and regulations pertaining to human subject research and DOH IRB policies.
• Advises investigators when they have questions about the IRB process or the determination of research.
• Assures investigators receive accurate and timely notification of IRB determinations; follows up with investigators regarding protocol changes, if any.
• Assists with the processing of research protocols including protocol review and management.
• Provides guidance on new studies, continuing review, and modifications.
• Assists with making improvements to the program website and IRB applications used by investigators and IRB members.
• Reviews and updates DOH program policies.
• Maintains active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development.
• Provides oversight of the AAHRPP efforts of the DOH, including working with AAHRPP staff, other members of the public health research office, and across divisions, to achieve, and/or maintain AAHRP criteria to ensure ongoing accreditation status.
• Assists as a subject matter expert on research programs and projects as needed.
• Performs other duties as assigned.

Benefits

• Annual and Sick Leave benefits
• Nine paid holidays and one Personal Holiday each year
• State Group Insurance coverage options, including health, life, dental, vision, and other supplemental insurance options
• Retirement plan options, including employer contributions
• Flexible Spending Accounts
• Tuition waivers

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed