PROTOCOL ANALYST LEAD

To review submitted protocols for areas within UAB that may include IRB, IACUC, RRSC, IBC, and others. Provide expert-level administrative and regulatory support for OIRB staff and IRB members, by independently leading convened IRB meetings. May serve as an IRB member for limited IRB reviews and HIPAA determinations related to exemptions, as well as protocols requiring expedited IRB review. Maintains an expert-level proficiency with the functions of the UAB eRA software. Mastery of the job duties of an IRB professional, including document comparison and finalization, composing IRB outcome letters, confirming prescriptive contingencies for approval based on IRB feedback, etc. Fluent understanding of UAB HRPP policies, procedures, and OIRB SOPs and reconciling with external policies and guidance (e.g., Federal Guidance, sponsor requirements, etc.) with the ability to advise investigators on compliance. Ability to conduct most day-to-day job functions with minimal to no managerial oversight. Coordinate with investigators to obtain needed changes to submissions before forwarding those to the Vice Chair, board, or others as necessary for review. May also coordinate protocols routed for central review within these areas.

Key Duties and Primary Responsibilities:

• Conducts Independently conducts reviews of any type of protocol applications for compliance with UAB institutional policies, federal regulations, DHHS regulations, AAHRPP policies and procedures, and any other requirements
• Reviews informed consent language for industry-sponsored research that require negotiations with the sponsor and only escalates, as necessary
• Conducts review of complex not regulated applications (QA/QI, Standard Public Health Surveillance, etc.)
• Communicates with investigators, students and faculty advisors regarding review results
• Addresses investigator's questions and/or concerns
• Reviews investigator's responses to reviewer's questions and suggested changes
• Has the ability run board meetings independently, and may attend to assist other staff, as necessary or due to absences
• Meets with others as needed to review their applications and answer questions. Compiles project review components for committee review
• Maintains necessary logs and documentation as required
• Assist less experienced staff in evaluating complex regulatory applications, able to do the cross check and know the regulatory basis of decision making
• Perform other duties as assigned

Annual Salary Range: $67,070 - $108,990

Bachelor's degree in related field and four (4) years of related experience required. Work experience may substitute for minimum education requirement. Must obtain a Certified IRB Professional (CIP) by the Public Responsibility in Medicine and Research (PRIM&R) within two (2) years of hire date. If eligible for CIP certification, must be certified within one (1) year of hire date.