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PROTOCOL ANALYST SENIOR

University of Alabama at Birmingham

University of Alabama at Birmingham

IT
university, fl, usa
Posted on Thursday, June 6, 2024
PROTOCOL ANALYST SENIOR - (T217609)

Description

PROTOCOL ANALYST SENIOR

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 the purposes of 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 reconcile 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. To coordinate with investigators to obtain needed changes to submissions before forwarding those to the Vice Chair, board or others as necessary

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 requires 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 to run board meetings independently, and may attend to assist other staff, as necessary or due to absences
  • May attend board meetings to assist other staff, as necessary or due to absences
  • Assist less experienced staff in evaluating complex regulatory applications, able to do the cross-check and know the regulatory basis of decision making
  • Performs other duties as assigned

Salary Range: $57,940 - $94,150

Qualifications

Bachelor's degree in related field and three (3) years of related experience required. Work experience may NOT 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.

Preferred Additional Qualifications:

  • Familiarity with Microsoft Office products
  • Strong attention to detail
  • Ability to work independently with minimal supervision
  • Experience providing mentorship to less experienced colleagues is a plus

Primary Location

: University

Job Category

: Other

Organization

: 120300000 Office Inst Review Board for Human Use

Employee Status

: Regular
Shift: Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite