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.
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.
License/Certification: 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 an 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 ability to independently organize, prioritize, and effectively deal with multiple ongoing activities.
The individual assumes responsibility to serve as an administrative coordinator and member of the IRB. Responsibilities include but are not limited to the following:
Initial evaluation of IRB correspondence to confirm application completeness.
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.
Assist the Director of Human Research Protection in general activities as needed in support of the overall functioning of the office.
Perform highly complex duties to facilitate the review and approval process, use of independent judgment in interpreting and applying relevant institutional policies and guidelines.
Provide assistance to faculty, staff, and student researchers in the preparation of applications.
Manage the compliance database for the appropriate tracking of research projects and generating reports regarding research actions and activities.
Creating 60 and 30 day expiration notices for investigators.
Working with student researchers to educate and support institutional compliance with research submissions.
Supplemental Posting Information
The IRB Coordinator will support Drexel University's commitment to the protection of human subjects participating in research and compliance with all institutional policies.
Interacts with faculty and staff within the University, possible interaction with various personnel from government agencies, and public and private sponsors.
Operates within policy, procedures and other guidelines established by the University and O.R. as well as all other applicable regulatory principles.
Work is in a professional office environment. Must be able to travel to committee meetings held at various University locations. Travel within the United States for conference and meeting attendance lasting multiple days is very likely.
Position hours in general are 8:00 a.m. to 5:00 p.m. however hours can vary based upon need.
Drexel University offers an attractive benefits package including tuition remission, a generous retirement package and an opportunity to join a talented team of professionals directly helping the University achieve its record growth and quality reputation.
Drexel University is an Equal Opportunity/Affirmative Action employer, welcomes individuals from diverse backgrounds and perspectives, and believes that an inclusive and respectful environment enriches the University community and the educational and employment experience of its members. The University prohibits discrimination against individuals on the basis of race, color, national origin, religion, sex, sexual orientation, disability, age, status as a veteran or special disabled veteran, gender identity or expression, genetic information, pregnancy, childbirth or related medical conditions and any other prohibited characteristic. Please visit our website to view all University Policies and Workplace Postings.
Background investigations are required for all new hires as a condition of employment, after the job offer is made. Employment may not begin until the University accepts the results of the background investigation.
Managing the IRB committee member's document requirements including current training, CVs and IT access to relevant IT platform required for IRB reviews.
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.
Additional Salary Information: Commensurate with experience
Internal Number: 9687 & 9686
About Drexel University
Drexel University (home of the Drexel Dragons) is a private, coeducational institution of higher learning. Located in Philadelphia, PA's West Philadelphia, Drexel is a world-class comprehensive research university committed to use-inspired research with real-world applications, and the University's research activities result in more than $110 million in annual expenditures for sponsored projects.
Research at Drexel is driven by faculty from all disciplines. Medical and health sciences research complements traditional strengths in engineering, biotechnology, basic science, information science, and business, alongside innovative scholarship in media arts and design, the social sciences, education, and law. The Office of Research at Drexel University is committed to facilitating these research efforts.
Clear examples of the University's interdisciplinary approach to research can be seen in efforts to meet emerging national imperatives to upgrade the transportation infrastructure, move alternative energy sources into the mainstream, and invent the means to improve medical care while reducing its costs. The University has also established major research initiatives in engineering cities, plasma medicine and biology, and neuroengineering.