Quality Assurance and Research Education Coordinator

Nemours is seeking a Quality Assurance and Research Education Coordinator . The purpose of the Q uality 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.

• 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

Primary 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.