Institutional Review Board Assistant

GBMC HealthCare•Towson, MD

3d•$20 - $30•Hybrid

About The Position

Under general supervision, the Institutional Review Board (IRB) Assistant pre-reviews and analyzes research project applications to ensure compliance with IRB policies and procedures, applicable federal regulations, and ethical guidelines for protecting human subjects. The role supports monthly IRB meetings by preparing agendas, attending meetings, documenting decisions, drafting minutes, and preparing determination letters. The Assistant is a primary contact for researchers and other research personnel, providing guidance on the IRB application process and the web-based IRB management system IRBNet. The position operates primarily remotely, with an expectation of in-office presence approximately one day per week. Candidates without IRB experience are welcome and training will be provided. The role is expected to demonstrate GBMC’s values of Respect, Excellence, Accountability, Teamwork, Ethical Behavior, and Results.

Requirements

Associate of Arts degree, or continuing studies toward a bachelor’s degree with at least 60 semester credit hours completed in a healthcare field.
Ability to learn and possess basic knowledge of federal regulations for the protection of human subjects in research, including 45 CFR Part 46 and 21 CFR Parts 50 and 56.
Strong computer skills, including experience with Microsoft Word, Excel, and Outlook.
Ability to learn and master the web-based IRB management system IRBNet.
Working knowledge of virtual meeting environments such as Webex, including the ability to screen share.
Detail-oriented, with a high degree of accuracy and reliability.
Excellent oral and written communication skills.
Ability to provide effective instructional guidance orally and in writing.
Strong knowledge of medical terminology.
Ability to multitask, set priorities, and manage time effectively.
Ability to meet deadlines.
Ability to function independently and work alone for long periods.
Ability to work effectively in a remote environment.

Nice To Haves

Zero to two years of experience working with an Institutional Review Board and/or Human Research Protection Program is preferred.

Responsibilities

Pre-review and analyze research project submissions received through IRBNet for completeness and compliance with GBMC IRB policies and procedures, federal regulations, and ethical guidelines; contact the appropriate individuals about incomplete submissions or required modifications and verify that modifications are made.
Prepare the monthly IRB meeting agenda in IRBNet, assign submissions to the agenda, order agenda items, and write a comment for each item.
Send monthly meeting reminders to IRB members, confirm attendance and quorum, and confirm attendance of individuals presenting new projects.
Assign primary reviewers for monthly IRB meetings and notify the assigned members.
Attend monthly IRB meetings via Webex, greet members and guests, record attendance, and manage technical meeting needs, including screen sharing the agenda.
Document IRB decisions and actions in IRBNet after monthly meetings.
Document project closures in IRBNet and the master project spreadsheet in Microsoft Excel.
Draft monthly IRB meeting minutes in IRBNet.
Prepare IRB determination letters in IRBNet after monthly meetings.
Prepare and deposit review fee payments, including external checks and internal department money transfers.
Pre-review submissions qualifying for expedited review by the IRB Chairperson and draft determination letters.
Maintain the list of investigators required to submit annual FCOI statements and their corresponding studies in Microsoft Word and the master spreadsheet in Microsoft Excel.
Prepare, track, and obtain signed annual conflict-of-interest statements from IRB members.
Assist with not-for-cause and for-cause post-approval monitoring audits.
Provide researchers and other key research personnel with guidance on the IRB application process and use of IRBNet.
Demonstrate GBMC Values in the performance of the role.