Quality Assurance and Research Education Coordinator

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.

About the Role

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.