The first round of applicant review will include resumes submitted by April 6, with a second round if needed for resumes submitted by April 20.
Under the general direction of the Director of Research Compliance (DRC) and in collaboration with other IRB Office staff members, the Senior Research Compliance Coordinator serves as an IRB Administrator and is responsible for the day-to-day operations of the UD IRB office and the human research protection program. The Sr. Research Compliance Coordinator is accountable for the oversight, implementation, and management of policies and procedures pertaining to human subject research activities. Tasks assigned to the Sr. Research Compliance Coordinator include reviewing, analyzing, and monitoring active human research protocols; ensuring compliance with all federal regulations, IRB Standard Operating Procedures (SOPs), and institutional policies; offering technical support, regulatory guidance, education, and training to faculty, researchers, and the IRB.
Administration and management of the IRB protocol review process. This includes assessing submissions for completeness; evaluating studies for their potential risk to participants; reviewing and analyzing research submissions in order to determine the risk level; and using complex regulatory knowledge to determine the most expeditious processing mechanism to be followed for each application.
Makes not-human-subjects research and exemption determinations; assigns non-exempt minimal risk research for review
Assists in the full board review process as a voting (or alternate) member. Prepares monthly meeting agendas and minutes documentation.
Directs and coordinates correspondence from the IRB office to investigators, reviewers, 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.
Serves as an expert resource on IRB requirements and human subjects protection issues. Develops and conducts human subjects training for faculty, staff, students and IRB members. Providing ongoing continuing education activities for IRB members.
Assist in the management and support of the ClinicalTrials.gov registration process and portfolio maintenance at UD.
Oversees and ensures compliance with complex federal and state regulations related to the protection of human research subjects. May assist in the conduct of periodic audits of research involving human subjects to assess compliance.
Assists in the maintenance and updates the Federal IRB registration and the UD Federal Wide Assurance (FWA). Participates in improving organizational performance and compliance components (e.g., required forms, SOPs, record keeping, policies, etc.)
Provides support to the DRC and performs other job-related duties as assigned.
Bachelor’s degree (BA/BS) in a relevant/applicable field required. Advanced degree preferred. Three years of related working experience in human subject protection, research administration, and/or compliance. Certified IRB Professional (CIP) preferred.
Demonstrated knowledge and understanding of federal and state regulations pertinent to research with human subjects and clinical trials. Experience with regulatory audits desired.
Excellent interpersonal and written/oral communication skills, including the ability to communicate effectively with diverse constituents.
Presentation skills and teaching/training experience preferred.
Proficient computer skills, including MS Office and database applications. Experience with IRBNet and/or other IRB electronic management systems desired.
Must be detail oriented, possess excellent organizational skills, and be able to handle multiple projects simultaneously.
Proven developed problem-solving ability and strong analytical capabilities.
Internal Number: 105383
About University of Delaware
The University of Delaware has a great tradition of excellence, from our founding as a small private academy in 1743, to the research-intensive, technologically advanced institution of today.
Our alumni tell our story of achievement, from our first class, which included three signers of the Declaration of Independence and one signer of the U.S. Constitution, to the more than 140,000 living Blue Hens who are making vital contributions to the world--in science, business, education, the arts, policy, health care, the environment, and many other areas. Vice President Joseph R. Biden Jr. and his wife, Jill, are both UD alumni.
The University received its charter from the State of Delaware in 1833 and was designated one of the nation's historic Land Grant colleges in 1867. Today, UD is a Land Grant, Sea Grant and Space Grant institution. UD also is classified by the Carnegie Foundation for the Advancement of Teaching as a research university with very high research activity--a designation accorded to less than 3 percent of U.S. colleges and universities.
A state-assisted, privately governed institution, UD offers courses in a broad range of disciplines, including 4 associate's p...rograms, 130 bachelor's programs, 79 master's programs and 39 doctoral programs through our seven colleges and in collaboration with more than 50 research centers. Our student body includes more than 16,000 undergraduates, 3,500 graduate students, and 1,000 students in professional and continuing studies from across the United States and around the world. Courses are offered across seven colleges: College of Agriculture and Natural Resources; College of Arts and Sciences; Lerner College of Business and Economics; College of Earth, Ocean, and Environment; College of Education and Public Policy; College of Engineering; and College of Health Sciences.
Among our distinguished faculty are internationally known authors, scientists and artists including Nobel Laureates, Guggenheim and Fulbright Fellows, members of the National Academy of Engineering, National Academy of Sciences, and American Association for the Advancement of Science, and a Pulitzer Prize winner.
State-of-the-art facilities support UD research, teaching, and public service activities. Our 146-foot coastal research vessel, Hugh R. Sharp, the most advanced in the United States, aids scientists across the region in exploring the sea. In 2009, UD launched a new airship that will assist in studying the Earth from above, with applications in geography, geology, coastal field biology, ecology and oceanography. World-class figure skaters train in our Ice Skating Science Development Center. And partnerships with renowned Nemours/A. I. du Pont Hospital for Children, Christiana Care, Thomas Jefferson University, Winterthur Museum & Country Estate, Longwood Gardens, and Hagley Museum offer students unparalleled experiences in cancer research to art conservation, horticulture, history and business.
Distinguished speaker series, symposia, 23 intercollegiate athletics programs, numerous intramural and club sports, more than 200 student organizations, concerts, exhibits, and other arts and cultural activities enrich campus life.
Thomas Jefferson once described Delaware as a "jewel" among states due to its strategic location on the East Coast, halfway between Washington, D.C., and New York City. Today, however, the location of Delaware's flagship university increasingly is being referred to as "halfway between Los Angeles and London."
In addition to our Georgian-inspired main campus in Newark, Delaware, UD has locations across the state--in Wilmington, Dover, Georgetown, and Lewes--and teaching facilities in London, Paris and China. A thriving study-abroad program and expanding international partnerships further enhance our students' education as global citizens.