Quality Assurance and Research Education Coordinator
American Society for Clinical Laboratory Science · Wilmington, DE · 3 wk ago
Other
About the Role
Nemours is seeking a Quality Assurance and Research Education Coordinator to ensure compliance with research protocols, federal and state regulations, ICH-GCP guidelines, and institutional policies. This hybrid position requires on-site presence in Wilmington, Delaware 30% of the time.
Qualifications
- Certified Clinical Coordinator (SOCRA or ACRP) required
- Bachelor’s degree required
- Minimum of 3 years of relevant experience
- Experience dealing with regulatory agencies
Responsibilities
- Ensure adherence to FDA regulations, ICH/GCP guidelines, local policies, and standard operating procedures for Sponsors, Investigators, and study teams.
- Assist in developing and writing clinical trial monitoring plans based on risk-based monitoring.
- Adhere to monitoring plans, including visit types, frequency, and critical activities, using tracking forms and templates.
- Monitor clinical trial progress through data review, on-site, and remote monitoring visits.
- Verify trial data consistency with patient clinical notes and source documentation (source data verification/review).
- Coordinate ongoing and upcoming monitoring assignments independently.
- Meet timelines for monitoring activities and submission of written reports.
- Provide recommendations and guidance to monitoring teams and assist in audit readiness.
- Develop and deliver training programs for clinical research associates.
- Participate in educating new team members and ongoing team training based on audit findings, regulatory changes, or policy updates.
- Travel up to 30% of the time as needed.
- Maintain strict confidentiality.