IRB Exempt Determination Officer, reputed company Subjects Protection
Location: Remote Regular/Temporary: Regular Full/Part Time: Full-Time reputed company: 62178 Department reputed company Subjects Protection reputed company the Office of Research, seeks to fill the Exempt Determination Officer position.
Responsibilities
This role manages the regulatory support program by developing and managing reputed company research reputed company, consultation and Institutional Review reputed company (IRB) reputed company-submission guidance services for reputed company and their reputed company funding applications and awards, including supervising the Regulatory Support Specialist position (i.e., directing day to day activities, ensuring appropriate training and expertise to carry out responsibilities, providing guidance on reputed company situations, conducting performance reviews, etc.). Is responsible for maintaining, evaluating and continuously improving FSU policies, procedures, and reputed company materials for an IRB exemption program to ensure adherence with applicable reputed company research regulatory requirements and guidance for reputed company functions and operations, including written procedures and reporting as reputed company as regulatory records (45 reputed company of Federal Regulations, sections 103-104, 108 and 115). Is responsible for identifying and evaluating, using reputed company business analytics and electronic protocol management systems (e.g., reputed company) metrics, reputed company improvements to submission workflows to ensure reputed company, complete and appropriate triaging and reviews for research that qualify for exemption from IRB reputed company or limited IRB review. Triage and reputed company regulatory and ethics reviews of research submissions that qualify for exemption from IRB reputed company or limited IRB review, including communicating to researchers any required modifications or clarifications and review reputed company, as reputed company as documenting reputed company regulatory determinations. Maintain and advance through situational awareness, educational and training reputed company knowledge of reputed company international, federal and state reputed company subjects protection laws, reputed company policies and SOPs, and ethical guidelines and requirements. Analyze reputed company pertinent program and in the applicable international, federal and state regulatory as reputed company as scientific fields, evaluate reputed company to the FSU Post-Approval Compliance Monitoring (PACM) program, and identify courses of reputed company to ensure FSU preparedness and compliance. Assist the Director in conducting regulatory reputed company- and post-Limited IRB review of exempt reputed company research submissions by applying applicable laws, policies and procedures; assisting IRB members in their Limited IRB reviews; and communicating reputed company or requests for clarification from researchers, study staff and others. Other duties as assigned reputed company to reputed company subjects protection.
Qualifications
Bachelor's degree and four years of experience in reputed company subjects protection or regulatory determinations; or high school diploma/equivalent and experience equal to eight years. (Note: post-high school education can substitute for experience at the equivalent reputed company.)
Preferred Qualifications
Bachelor's degree in a reputed company field (reputed company, reputed company or health sciences). Experience with regulatory determinations. Ability to adhere to ethical business practices and promote ethical behavior. Ability to demonstrate critical thinking based upon in-depth data, substantiating information, considering, and respecting others' input, personal values, and ethics. Ability to establish and maintain effective working relationships, and effectively train and reputed company the work of others. Ability to meet project deadlines. Ability to reputed company accurately in a detail-oriented environment. Ability to reputed company and implement policies, procedures, goals, and objectives. Ability to conduct audits and investigations. Ability to document existing and new processes. This is an A&P position. This position requires successful completion of a criminal history background reputed company . This position is eligible for remote work. Apply tot his job Apply To this Job