University of Delaware

PAY GRADE: 31E

CONTEXT OF THE JOB:

The research enterprise at the University of Delaware exceeded $325M in sponsored program expenditures in fiscal year 2023. This included over 1400 proposals submitted and more than 700 new awards received totaling approximately $390M. During fiscal year 2023, there were more than 2100 active awards, over 1700 Institutional Review Board submissions, over 100 animal protocols, more than 120 Material Transfer Agreements, and more than 5900 Effort Certification Reports.

The Research enterprise is integral in furthering the commitment to excellence at the University of Delaware (UD). UD’s Research Office is charged with serving as an advocate for UD faculty, students and researchers as they pursue research and assist them to ensure compliance with all associated policies and procedures. At UD all research involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data must be reviewed by the Institutional Review Board (IRB). 

Under the general direction of the Director of Research Compliance (DRC), the Senior Research Compliance Specialist serves as an IRB Member and Administrator, is responsible for the day-to-day operations of the UD IRB office and the human research protection program. The Sr. Research Compliance Specialist is accountable for the oversight, implementation, training, and management of policies and procedures pertaining to human subject research activities. Tasks assigned to the Sr. Research Compliance Specialist include triaging, reviewing, analyzing, and monitoring active human research protocols; ensuring compliance with all federal regulations, IRB Standard Operating Procedures (SOPs), and institutional policies; providing technical support and regulatory guidance to the IRB, investigators, and their support staff; and providing education and training to faculty, researchers, and the IRB.

MAJOR RESPONSIBILITIES:

• Facilitates, manages, and triages the IRB protocol review process. This includes conducting pre-reviews; assessing submissions for completeness; evaluating studies for their potential risk level to participants; and using complex regulatory knowledge to determine the most expeditious and appropriate processing path to be followed for each application.
• Makes non-human-subjects research and exempt determinations based on expert knowledge of applicable regulations; assigns for review as appropriate non-exempt minimal risk research. Serve as an IRB member and conduct reviews and approvals of expedited submissions.
• Conducts accurate data entry and maintenance of all protocol review activities.
• Oversees and ensures compliance with federal and state regulations related to the protection of human research subjects.
• Consults with researchers and various University stakeholders and serves as an expert resource on IRB requirements and human subjects protection issues. Answers questions, concerns, and unexpected events in a timely fashion.
• Directs and coordinates the correspondence from the IRB office to investigators, reviewers, research participants, and other institutional IRBs as needed. Serves as a point of contact for the IRB office in multisite/inter-institutional research projects requiring IRB reliance agreements and facilitates their execution. Facilitating the execution of agreements may require use of supplemental electronic reliance management systems (e.g., SMART IRB.org)
• Assists in the management and support of the ClinicalTrials.gov registration process and portfolio maintenance at UD.
• Manages single IRB review collaborations and reliance agreements processing as assigned.
• Assists in the conduct of post-approval quality assurance activities and periodic audits of research involving human subjects to assess compliance. Evaluates reports of unanticipated problems and recommends appropriate follow up. 
• Develops and conducts human subjects training for faculty, staff, students, and IRB members. Provide ongoing service and education to the university community on human research subjects protection related issues and emerging requirements. 
• Assists in the maintenance and updates the U.S. Office of Human Research Protection and the Federal Drug Administration IRB registration and the UD Federal Wide Assurance as needed.
• Initiates, designs, modifies, and otherwise participates in improving organizational performance and compliance components such as required forms, SOPs, record keeping, and institutional policies in reference to the protections of human subjects in research.
• Provides support to the DRC, and performs miscellaneous job-related duties as assigned.

QUALIFICATIONS:

• A minimum of 5 years of experience with a bachelor’s degree in biomedical, behavioral, and/or social sciences, or 2 years of experience with an advanced degree is required.
• Experience shall be in a human subjects protection program, compliance role, and/or in research administration.
• Experience with biomedical, behavioral and/or social sciences research is desirable.
• Certification as an IRB Professional (CIP) is desirable.
• Advanced knowledge of federal regulations, state and local laws, plus institutional requirements related to human research subjects protection.
• Demonstrated ability to interpret, apply and communicate federal and institutional guidelines, regulations, statutes, and institutional policies.
• Experience implementing compliance programs and conducting regulatory audits.
• Established decision-making skills and demonstrated analytical ability.
• Demonstrated ability to make accurate and appropriate independent judgments issues.
• Strong organizational and time management skills.
• Ability to identify, prioritize, and pro-actively manage high volume workload, meet deadlines, and support multiple individuals simultaneously maintaining a high degree of accuracy and attention to detail.
• Effective interpersonal and written/oral communication skills. Ability to communicate with individuals from different disciplines and backgrounds.
• Highly collaborative and customer-service oriented.
• Committed to fostering and supporting an inclusive culture where diversity is embraced, and equity is a core value.
• Presentation skills and teaching/training experience developing educational content.

Proficient computer skills, including MS Office and database applications. Experience with electronic submission systems required.