Institutional Review Board Manager – Remote Eligible: CORP – Instit Review Bd – Irb in Hollywood, FL

Institutional Review Board Manager - Remote Eligible: CORP - Instit Review Bd - Irb - Memorial Healthcare System - Hollywood, FL - work from home job Company: Memorial Healthcare System Job description: Summary: Manages IRB analysts and coordinates the day-to-day activities of the IRB office, including review of research protocols for regulatory compliance, protocol review management, and assistance with the meetings of the Board. This role reports to the IRB Director. Detailed responsibilities:

• Directly manages IRB Analysts. Delegates responsibilities and monitors accuracy, quality, and timeliness of work. Reports outcomes to the IRB Director.
• Serves as a subject matter expert on DHHS and FDA regulations related to protections of human subjects in research. Assists the IRB Director with revisions to institutional policies and procedures.
• Conducts reviews of complex scientific research protocols to ensure compliance with DHHS and FDA regulations. Determines applicable review types, identifies regulatory and ethical issues and facilitates revisions to the submissions. Makes final outcome determinations for submissions and communicates them to the IRB Director, Board Members and study staff.
• Serves as the alternate voting member for the IRB Director and moderates IRB meetings as needed. Drafts and distributes agenda and materials to the IRB members ahead of meetings along with official meeting minutes after the meeting. Summarizes any controverted issues, their resolution and Board s action. Generates IRB correspondence related to action items and outcomes on each submission.
• Maintains up-to-date knowledge of DHHS and FDA regulations related to protection of human subjects in research.
• Maintains advanced knowledge of the electronic IRB submission system and future upgrades. Assists with the system set up and revisions of application forms and templates.
• Assists and performs additional tasks related to day-to-day operations of the IRB office as assigned by the IRB Director. Competencies and skills: Essential:
• STANDARDS OF BEHAVIOR: Acts in a manner that supports the standards of communication, respect, privacy, and teamwork by demonstrating a commitment to professional and ethical conduct.
• CUSTOMER SERVICE: Demonstrates commitment to service excellence by promptly addressing internal/external customer issues/requests, resolving concerns while maintaining a professional image and behavior to build and enhance the patient/family/customer experience.
• ACCOUNTABILITY: Accepts ownership of job roles and specific assignments/goals; works independently, takes responsibility for own actions; admits mistakes and judgment errors; and accepts constructive feedback. Connects personal work results to the accomplishment of team and organizational goals.
• RESPONDING TO CHANGE: Accepts change and adapts in a positive and productive manner; handles unexpected situations and changes in direction calmly and with confidence. Views new assignments and job responsibilities as an opportunity for growth.
• ANALYSIS AND DECISION MAKING: Uses decision making processes and tools to analyze situations and make effective decisions.
• PROBLEM SOLVING: Ability to identify, analyze and effectively solve problems.
• MANAGING PEOPLE: Uses HR/Performance Management processes and systems to align individual performance to achieve organizational results. Education: Essential:
• Masters Credentials: Essential:
• Certified IRB Professional Education equivalent experience: Essential:
• in a research or science related field. Other information: Complexity of Work: This role requires critical thinking skills, effective communication, decisive judgment, and the ability to build and foster positive relationships. The incumbent must be able to lead others and take appropriate action when required. Required Work Experience: Five (5) years of experience as a reviewer of scientific studies for compliance with DHHS and FDA regulations. Working conditions: Essential:
• Keyboard Entry 80.00%
• Repetitive Movement Hand/Arm 80.00%
• Sitting 80.00%
• Standing 80.00%
• Walking 80.00%
• Audible Speech 80.00%
• Hearing Acuity 80.00%
• Depth Perception 80.00%
• Distinguish Color 80.00%
• Seeing - Far 80.00%
• Seeing - Near 80.00%
• Computer Monitor 80.00% Organizational Profile: Since its inception in 1953, Memorial Healthcare System has been a leader in providing high-quality healthcare services to South Florida residents. Today, it is one of the largest public healthcare systems in the nation with over 13,000 team members and highly regarded for its exceptional patient- and family-centered care. Memorial's patient, physician and employee satisfaction rates are some of the most admired in the country, and the system is recognized as a national leader in quality healthcare. Memorial has a reputation as one of Florida's leading healthcare systems and is supported by a distinguished medical staff. In fact, the vast majority of physicians are board c

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