Quality Assurance and Research Education Coordinator

The Nemours Foundation; 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 Research Education Coordinator. The purpose of the Quality Assurance Research Coordinator position is to ensure compliance with respective research protocols, applicable federal and state regulations, ICH-GCP guidelines and all relevant institutional policies and procedures. The Research Quality Assurance and Education coordinator will provide internal monitoring and educational opportunities for Nemours Biomedical Research to support these objectives.

This is a Hybrid position. Candidate must be able to be on site in Wilmington, Delaware 30% of the time.

Qualifications:

• Certified Clinical Coordinator 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

Responsibilities:

• Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
• Assist in the development and writing of clinical trial monitoring plans based on risk based monitoring.
• Adhere to monitoring plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
• Monitor clinical trial progress through a combination of data review and on site/remote monitoring visits.
• Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
• Independently coordinate ongoing and upcoming monitoring assignments
• Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
• Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
• Provides training programs for clinical research associates developed by the Quality Assurance and Research Program.
• Participates in education of new team members as well as ongoing education of teams based on gaps identified through internal audits, sponsor monitoring visits, changes in regulations, departmental/corporate policies and other factors as determined by department leadership
• Must be willing to travel up to 30% of the time as needed
• Must be able to maintain strict confidentiality.