Hybrid Clinical Research QA & Education Coordinator

Nemours; Wilmington (DE); Hybrid; USD 70,000 - 90,000; Full time

Job summary

The Nemours Foundation in Wilmington, Delaware is seeking a Quality Assurance and Research Education Coordinator to ensure compliance with research protocols and federal regulations. This hybrid position requires being on site 30% of the time.

The ideal candidate will have a Bachelor's degree, certification as a Clinical Coordinator, and a minimum of 3 years of relevant experience in clinical research. Responsibilities include regulatory oversight, education, and internal monitoring to support Nemours Biomedical Research.

Qualifications

• 3+ years of relevant experience in clinical research.
• Experience dealing with regulatory agencies.
• Ability to maintain strict confidentiality.

Responsibilities

• Ensure compliance with FDA regulations and ICH/GCP guidelines.
• Assist in developing clinical trial monitoring plans.
• Conduct ongoing monitoring visits and submit reports.
• Train clinical research associates based on audit findings.

Skills

Clinical research monitoring

Regulatory compliance

Training program development

Education

Bachelor's degree

Certified Clinical Coordinator (SOCRA or ACRP)

Job description

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.

Essential Functions

• 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

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