IRB Project Coordinator II

Overview

The Institutional Review Board (IRB) Project Coordinator II plays an integral role in the review of human subject research at Drexel University. As a designated reviewer for the IRB, the Project Coordinator II will participate in, as appropriate, the review and approval process for Full and Expedited applications (Initial and Continuing, Modifications/Amendments, Reportable New Information and Final reports), and Exempt Category projects. The IRB Project Coordinator will work with a diverse group of researchers, staff, faculty, students, and with various University committees and offices, such as the General Counsel's Office, Institutional Biosafety Committee, Radiation Safety Committee, and Conflict of Interest Committee. Additionally, the IRB Project Coordinator will foster a culture of compliance, while simultaneously meeting the customer service needs of the Drexel research community.

The IRB Project Coordinator II will help to prepare and arrange for the research approval activities related to the operation of the IRB throughout the operational and regulatory review process. Activities include creating meeting agendas, review of applications, attendance at Full Convened IRB meetings, preparation of meeting minutes and post-review correspondence. When required the IRB Program Coordinator will assist investigators in developing their protocols and informed consent forms by offering expertise in study design, statistics, and the regulations regarding human subject research. The Project Coordinator may also develop and present IRB-related trainings that assist the research community such as the submission process and compliance topics.

Essential Functions

IRB Protocol Management Including

•             Initial evaluation of IRB correspondence to confirm application completeness

•             Perform highly complex duties to facilitate the review and approval process, use of independent judgment in interpreting and applying relevant institutional policies and guidelines.  

•             Request additional information from the principal investigators as necessary prior to IRB review.

•             Preparation and distribution of IRB review materials in an electronic/paperless manner.

•             Assure initial, continuing review and modification reviews of human research protocols are in accordance with Federal, HIPAA, State, local regulations and Institutional policies throughout the review process.

•             Formulation of meeting agendas, recording meeting minutes, communicating and corresponding with IRB Chair, IRB members as well as investigators and their staff.

•             Entry of compliance related activities and maintenance of IRB Coeus database.

•             Manage the compliance database for the appropriate tracking of research projects and generating reports regarding research actions and activities.

Customer Service Including

• Provide assistance to faculty, staff, and student researchers in preparation of applications.
• Creating 60 and 30 day expiration notices for investigators.
• Working with student researchers to educate and support institutional compliance with research submissions.
• Managing the IRB committee member's document requirements including current training, CVs and IT access to relevant IT platform required for IRB reviews.

Office and Team Development Including:

• Assist the Director of Human Research Protection in general activities as needed in support of the overall functioning of the office
• Managing and maintaining compliance requirements to maintain Federal Wide Assurance (FWA) in relation to the IRB
• Responsible for Oversight of new IRB member training.

Other duties as assigned