Full employer posting
Nemours is seeking a Quality Assurance and Education Coordinator to join our team in Wilmington, DE. Primary Function The Research Quality Assurance and Education Coordinator supports compliance with research protocols, federal and state regulations, ICH:GCP guidelines, and institutional policies. This position conducts QA monitoring, provides education, and promotes high-quality research practices across Nemours Biomedical Research.
This is a Hybrid position. Candidates must be located in DE, PA, NJ or MD. Candidate must be able to be on site in Wilmington, Delaware 30% of the time.
Ensure sponsors, investigators, and study teams comply with applicable regulations, guidelines, policies, and standard operating procedures. Develop risk-based clinical trial monitoring plans. Conduct data reviews and onsite or remote monitoring visits.
Verify trial data against clinical notes and source documentation. Coordinate monitoring assignments and complete reports within established timelines. Provide monitoring guidance and support audit readiness.
Develop and deliver training for clinical research associates and research teams. Identify educational needs based on audits, monitoring visits, regulatory changes, and organizational policies. Maintain strict confidentiality.
Travel up to 30% as needed. Requirements Certified Clinical Research Coordinator or Professional either through SOCRA or ACRP required Bachelor's degree required A minimum of 3 years of relevant experience required Experience dealing with regulatory agencies required Pediatric experience preferred #LI-RR1
Full time
About the role
Ensure sponsors, investigators, and study teams comply with applicable regulations, guidelines, policies, and standard operating procedures.