As one of the nation’s leading pediatric health care systems, Nemours is committed to providing all children with their best chance to grow up healthy. We offer integrated, family-centered care to more than 300,000 children each year in our pediatric hospitals, specialty clinics and primary care practices in Delaware, Florida, Maryland, New Jersey and Pennsylvania. Nemours strives to ensure a healthier tomorrow for all children – even those who may never enter our doors – through our world-changing research, education and advocacy efforts. At Nemours, our Associates help us deliver on the promise we make to every family we have the privilege of serving: to treat their child as if they were our own.
The IRB Coordinator is responsible for: Assuring effective functioning of the assigned Institutional Review Board or Boards including pre-meeting, in-meeting, and post meeting research review activities as required by applicable law, regulation and Nemours policy and procedure.
Works in concert with the IRB Chairperson(s) to assure that all research and related items submitted to the IRB(s) are reviewed and acted upon in a timely manner in accordance with NOHSP policy and estabished Nemours IRB performance standards.
Assures that all IRB members have timely access to all materials and resources required for them to conduct adequate reviews of IRB submissions. Assists members as required to obtain answers to questions not provided via submitted material and facilitates their ability to effectively utilize the IRB components of IRBNet.
Assures that agendas are available to members in IRBNet prior to each meeting, as well as any educational materials.
Takes accurate and complete notes of IRB discussion, controversies, determinations, motions and other items as required by NOHSP policy and Federal regulation during convened IRB meetings. Utilizes meeting notes and pre-submitted reviewer forms and comments to create complete and accurate meeting minutes
Creates, reviews with the Chair, and distributes on a timely basis all official IRB correspondence, documents and reports as required by NOHSP policy and federal regulation. Enters appropriate IRB actions and other elements into the IRBNet system as required by policy and procedure.
Meets the production standards and customer service standards established by NOHSP, the most recent version of which is available on the Nemours shared computer drive and distributed / discussed at staff meetings.
Participates actively in NOHSP staff meetings and NOHSP Leadership meetings. Contributes and implements ideas designed to improve the functioning of the IRBs and provide exceptional customer service to IRB stake-holders.
Accurately, and on a timely basis maintains and updates the IRB Membership Roster with the Office of Human Research Protections (DHHS)
Participates as assigned by the Director, NOHSP in the development and implementation of quality improvement projects for the IRBs
Acts as liaison in the event of FDA government audit/Nemours internal audits IRB/PI.
Maintains current knowledge of federal regulatory and compliance requirements by attending conferences and shares the information with IRB/NOHSP.
Suggests QA/QI improvements relating to Nemours Human Subjects Policies and Compliance at department monthly staff meetings.
Achieves an average quarterly rating for my IRB of 3.5 for IRB correspondence satisfaction (researcher evaluation survey
Coordinates IRB meetings; prepares agenda and material to meet distribution deadline; reviews materials with IRB Chairs; monitors existing and new protocols; expedites approvals; reviews and approves exempt applications.
Gathers information and background material in response to inquiries/issues raised; responds to requests for information regarding IRB review.
Leads special projects identified and assigned by IRB Leadership.
Assists with revisions and implementation of IRB forms, policies, and standard operating procedures.
Informs Leadership of issues raised by the IRB or investigators; performs other duties as assigned.
Excellent communication skills
Excellent computer skills
Ability to work as a team member across campuses with a high level of cooperation and supportiveness
Ability to read, interpret and communicate regulationsrelated to Human Subject Protections
Basic understanding of research ethics principles
Exceptional customer service skill
Bachelor's degree required
The associate will be required to achieve their Certification in IRB Management (CIM) no later than the third year of employment.
Our dedication to professionals who are dedicated to children frequently earns Nemours a spot on the list of top workplaces in the communities we serve. Our Associates enjoy comprehensive benefits, including our unique “Bridge to a Healthy Future” pediatric health plan, an integrated wellness program, opportunities for professional growth, and much more. As an equal opportunity employer, Nemours focuses on the best-qualified applicants for our openings.
Nemours is a pediatric health system of hospitals and specialty clinics serving children and families throughout the Delaware Valley and Florida. Our dedicated professionals integrate medical care, research, health education, and prevention to help improve the lives of children every day.