Regulatory Coordinator

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🏈 Alabama, Colorado, +13 more states – Remote

🏈 Alabama – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🦀 Maryland – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

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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

• Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth. • Verify NCORP protocols within Nemours CTMS. • Provide regulatory support for research programs and oversee maintenance of required regulatory documents. • Provide regulatory start-up support for research teams across clinical trials. • Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials. • Oversee timely regulatory submissions to meet project timelines. • Oversee the electronic regulatory binder (eReg) system and ensure accurate, complete, audit-ready documentation aligned with GCP, ALCOA-C principles, and institutional requirements. • Establish and maintain standardized processes for document collection, version control, review, approval, and filing within the eReg system. • Ensure timely upload, QC review, and lifecycle management of essential documents, including protocols, investigator brochures, IRB approvals, safety reports, and delegation logs. • Identify program improvement opportunities and lead team improvement efforts, including technology solutions and expansion of solutions to study teams. • Coordinate with departments to address regulatory quality and compliance matters. • Assist with regulatory training development and provide education on eReg use and regulatory documentation standards. • Work with Quality Assurance on internal audits and quality assurance reviews of regulatory files and electronic regulatory binders. • Write and edit clinical research protocol consent forms in accordance with federal regulations, guidelines, and GCP. • Liaise with personnel, departments, and external entities on clinical trial regulatory operations.

🎯 Requirements

• Bachelor's degree in Clinical Health Science or Healthcare Administration. • One to three years of regulatory coordination experience. • Two years of clinical research experience preferred. • Experience with electronic regulatory binder systems, such as Florence eBinders, Veeva eTMF, or equivalent, strongly preferred. • Demonstrated understanding of GCP documentation standards and audit readiness expectations.