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Quality Assurance and Research Education Coordinator
Center for Health Care StrategiesQuality Assurance and Research Education Coordinator at Nemours ensuring compliance with FDA regulations in clinical trials. Overseeing monitoring activities and providing education to clinical research associates.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Center for Health Care Strategies Website LinkedIn All Job Openings 51 - 200 employees Founded 1998 ⚕️ Healthcare Insurance 🤝 Non-profit 🌍 Social Impact Healthcare Insurance
- Non-profit
- Social Impact 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. Quality Assurance and Research Education Coordinator Job not on LinkedIn 🔥 1 minute ago 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) Google Cloud Platform Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 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 Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs QA Engineer 🔥 15 minutes ago Bridgeway Benefit Technologies 201 - 500 ☁️ SaaS 👥 HR Tech Website LinkedIn All Job Openings QA Engineer at Bridgeway Benefit Technologies ensuring quality, reliability, and performance of software products through testing practices. Collaborating with teams to improve user experience and reduce post-release defects. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) Azure Java JavaScript Python SQL Utilization Management RN 🔥 36 minutes ago GuideWell Source 1001 - 5000 ⚕️ Healthcare Insurance 🏛️ Government 🏢 Enterprise Website LinkedIn All Job Openings Utilization Management Compliance Specialist role requires an RN with 5+ years experience. Join Florida Blue to support compliance with CMS and NQCA guidelines. 🇺🇸 United States – Remote 💵 $77.6k - $126.1k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) 🦅 H1B Visa Sponsor Senior Associate, Data Quality Engineering 🔥 40 minutes ago Fortitude Re 201 - 500 💸 Finance ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Data Quality Engineer responsible for designing and maintaining data quality frameworks at Fortitude Re. Collaborating with teams to ensure data accuracy and compliance across lifecycle processes. 🇺🇸 United States – Remote 💵 $120k - $130k / year ⏰ Full Time 🟠 Senior 🔧 QA Engineer (Quality Assurance) AWS Azure Cloud ETL Google Cloud Platform Pandas Python SQL Quality Assurance Engineer 🔥 3 hours ago PublicInput 11 - 50 🏛️ Government ☁️ SaaS Website LinkedIn All Job Openings Quality Assurance Engineer safeguarding customer experience and ensuring software reliability for public engagement platforms. Collaborating closely with engineers and product managers to develop comprehensive testing strategies. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) ASP.NET Azure Cypress Java JavaScript jQuery Python React Selenium SQL TypeScript .NET Quality Assurance Analyst 🔥 4 hours ago Agero, Inc. 1001 - 5000 🚗 Transport Website LinkedIn All Job Openings Quality Assurance Analyst redefining driver ownership experiences through data-driven technology at Agero. Strengthening client relationships while managing a national network of service providers. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) View More QA Engineer Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs
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Hard Skills & Tools
clinical trial monitoringsource data verificationdata reviewrisk based monitoringmonitoring plansmonitoring tracking formsaudit readinessreport writingtraining program developmentregulatory compliance
Soft Skills
communicationorganizationalindependent coordinationrecommendationguidanceeducationteam collaborationconfidentialitytime managementproblem solving
Certifications
Certified Clinical CoordinatorSOCRA certificationACRP certification