PROTOCOL ANALYST ASSISTANT

University of Alabama at Birmingham•University, MS

43d•$21 - $34

About The Position

To review active human subjects research projects for renewals and amendments; provide administrative and regulatory support to assigned team, as well as IRB members. Become familiar with the functions of the UAB eRA software. Gain a general understanding 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. Gain a general understanding of UAB HRPP policies, procedures, and OIRB SOPs. To serve as a liaison with investigators and other research administration offices and manage regulatory records for the IRB.

Requirements

Bachelor's degree in a related field required.
Work experience may substitute for education requirement.

Responsibilities

Facilitates continuing review of active projects to ensure compliance with current regulatory and institutional requirements.
Reviews Investigator Progress Reports, study protocols, grant applications, and consent and assent forms submitted for continuing review.
Works directly with investigators to obtain missing information required for review by the board or expedited reviewer and serves as the liaison between the board/expedited reviewer and the investigator for any revisions required in order to grant continuing IRB approval.
Processes minor amendments to active projects for review by the board or expedited reviewer.
Serves as a liaison with other offices (OSP, CIRB) and processes reports generated by these offices from IRAP.
Alerts the OIRB regulatory compliance manager of suspected issues of noncompliance.
Attends board meetings, takes notes including vote counts, regulatory determinations, etc.
Stays abreast of current federal and state regulations and guidance, as well as UAB institutional policies related to human subjects research.
Maintains investigator training records and the departmental website, facilitating agreements and reviews with external IRBs, and preparing correspondence and minutes from board meetings.
Performs other duties as assigned.