Quality Assurance and Research Education Coordinator

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🕒 June 1

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Center for Health Care Strategies

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Center for Health Care Strategies is a U. S. -based organization dedicated to improving the healthcare system to achieve better and more equitable outcomes, particularly for those served by Medicaid. The center focuses on issues like complex health and social needs, mental health, substance use, and aging and disability. It emphasizes cross-sector partnerships, community engagement, and health equity to transform the delivery system and promote value-based payments. The organization also supports leadership and capacity building efforts to drive system reform, including integrating Medicare and Medicaid services and advocating for trauma-informed care and primary care innovation.

📋 Description

• 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.

🎯 Requirements

• 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