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 comm unity such as the submission process and compliance topics.
The Project Coordinator II must maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research. Performs other duties as assigned.
High School Diploma or equivalent required. Bachelor degree in a health science related field preferred.
A minimum of 1 year career experience in the role of IRB coordinator preferred.
Current Certified IRB Professional (CIP) preferred, or candidate will obtain CIP within three years of hire.
Strong working knowledge of FDA, OHRP, HIPAA and FERPA regulations and guidelines.
Function with minimal supervision and possess excellent communication and analytical skills.
Ability to interact with individuals at multiple levels and disciplines.
Able to coordinate multiple projects simultaneously.
Excellent organizational skills and the ability to independently prioritize work activities.
Attention to detail required for reviewing research project applications.
Demonstrate competence in database management and high degree of experience working with Microsoft Word, Excel and Outlook.
Experience with Coeus and Hyperion database management applications.
Ability to exercise sound judgment, function effectively and professionally meeting deadlines.
Flexible work schedule, start of workday may vary based upon IRB meeting schedules.
Maintain confidentiality of workplace information according to the policies and procedures of the institution.
Excellent verbal and written communication skills required.
Excellent time management skills with the ability to independently organize, prioritize, and effectively deal with multiple ongoing activities.
Philadelphia, PA 19102