Assistant Director, Human Research Protection Program
Drexel is a comprehensive global research university ranked among the top 100 in the nation. With over 24,000 students, Drexel is one of America's 15 largest private universities. Drexel is one of Philadelphia's top 10 private employers, and a major engine for economic development in the region. Drexel has committed to being the nation’s most civically engaged university, with community partnerships integrated into every aspect of service and academics.
The Office of Research & Innovation’s Human Research Protection Program is seeking an Assistant Director of the Institutional Review Board. The incumbent in this position partners closely with the Director of Human Research Protection to ensure the regulatory requirements for submissions to IRB are met. Additionally, this position leads the customer service interactions for the IRB, oversees the development and delivery of educational offerings held by the IRB team to foster understanding of the IRB process. The ideal candidate has knowledge of federal, state, and local requirements, laws, and regulations related to social/behavioral and biomedical human research. This candidate has the proven ability to perform high-quality reviews of all types of applications submitted to the IRB. This position frequently interacts with various stakeholders in the Drexel Community and acts as a conduit of information leading to the successful submission of various protocols and applications.
- Partners with other stakeholders and units to ensure collaborative implementation of policies within all research compliance.
- Attends relevant committee meetings and presents updates related to the IRB program to stakeholders in the University Community.
- Managing HRPP staff and provides oversight in protocol reviews ensuring compliance with federal, state, local regulations as it related to IRB.
- Manages all aspects related to IRB operations including but not limited to the research life cycle, Board management, Reliance Agreements, and required reporting duties to federal agencies, the University, accreditation, and outside parties such as sponsors/funding sources.
- Conduct protocol review activities, assure review assignments and the process is conducted by appropriately trained/experienced staff and IRB members.
- Manage the processing of research protocols involving human subjects throughout the review process; assign protocols for review by HRP staff and IRB members.
- Oversee the development and delivery of training sessions for the OR&I staff, researchers, students, and other groups in collaboration with the Director of Human Research.
- Regular quality assurance audits of the Coeus database for all research projects processed through the IRB.
- Develop educational material for weekly HRP Office staff meetings.
- Create educational materials for University.
- Assist and educate investigators in preparing IRB applications and reporting activities post IRB approval.
- Identify and define inconsistencies in research protocol applications submitted for review in addition to identifying inconsistencies during the ongoing review process in accordance with institutional policy and federal regulations.
- Conduct primary review for Exempt and Expedited protocols and administrative approval actions.
- Attend monthly IRB meetings for each IRB committee.
- Other duties as assigned.
- Bachelor’s Degree
- A minimum of 1-3 years of relevant work experience
- At least 1-2 years of experience in a supervisory/management capacity
- Ability to work in collaboration with ancillary committees, investigators, research staff, supporting administration, and sponsors/funding agencies to ensure compliance with regulatory and other contractual obligations.
- Ability to work independently, with minimal direction and guidance with a service-team environment.
- Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
- Excellent written and verbal communication skills.
- Strong leadership and mentorship skills with a desire to continue to grow these skills.
- In-depth knowledge of and experience with Microsoft Office (Word, Excel, SharePoint, OneDrive, PowerPoint, and Planner).
- Experience in working with electronic research administration software.
- Strong analytical and problem solving-skills.
- Have current CIP certification or be willing to achieve this certification.
- Experience in research design, operations, or regulatory compliance related to human research.
- Advanced working knowledge of OHRP, Federal Rule, HIPAA, ICH-GCP, research operations and FDA regulatory processes for drugs and medical devices.
- Well versed in medical and regulatory compliance terminology.
- Excellent organizational skills, ability to prioritize work independently with strong attention to detail.
- Typically sitting at a desk/table
- Typically standing, walking
- Lifting demands < 25lbs
Remote, Philadelphia, PA
This position is classified as Exempt with a salary grade of M. For more information regarding Drexel’s Professional Staff salary structure, https://drexel.edu/hr/career/ducomp/salstructure/
Special Instructions to the Applicant
Please make sure you upload your CV/resume and cover letter when submitting your application.
Review of applicants will continue until a suitable candidate pool is identified.