Quality Assurance and Research Education Coordinator

Nemours is seeking a Quality Assurance and Research Education Coordinator. ThepurposeoftheQuality Assurance Research Coordinator position is to ensure compliance withrespective 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 monitoringandeducationalopportunities for Nemours Biomedical Research to support these objectives.

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

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.

Originally posted on Himalayas