PROTOCOL ANALYST

PROTOCOL ANALYST

The University of Alabama at Birmingham

General Responsibilities:
To review submitted protocols for areas within UAB that may include IRB, IACUC, RRSC, IBC and others. To begin providing administrative and regulatory support for OIRB staff and IRB members at convened IRB meetings. Become proficient with the functions of the UAB eRA software. Gain a proficiency with 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. Gain a proficient understanding of UAB HRPP policies, procedures, and OIRB SOPs. To 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 & Responsibilities:

1. Conducting pre-reviews for new and revised projects prior to review by the convened IRB or an expedited IRB reviewer.
2. Reviewing projects that are exempt from the regulations requiring IRB review.
3. Conducts reviews of protocol applications for compliance with UAB institutional policies, federal regulations, DHHS regulations, AAHRPP policies and procedures, and any other requirements.
4. Conducts reviews of amendments that may involve more than minor issues, to approved protocols. Resolves investigator issues using problem-solving techniques.
5. Assists with reviewing continuing reviews of active protocols, as necessary.
6. 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.
7. Attends board meetings and works with Protocol Analyst I staff to complete meeting minutes in a timely manner.
8. 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.
9. Performs other duties as assigned.

Salary Pay Range: $50,050 - $81,330

Qualifications

Minimum Requirements:
Bachelor's degree in related field and one (1) year of related experience required. Work experience may substitute for minimum education requirement.

Preferences:
* Proficiency with Microsoft 365 applications and other electronic systems, such as UAB's electronic research administration system, IRAP.
* Strong attention to detail, ability to work independently with minimal supervision.
* Experience providing mentorship to less experienced colleagues is a plus.
* Prior IRB experience and CIP certifications are pluses.
* Experience with human subjects' research and/or clinical research.