Care Access

Clinical Research Coordinator I

Raleigh, North Carolina, United StatesFull timePosted 10 days ago
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About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com.How This Role Makes a Difference The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prescreen study candidates   Obtain informed consent per Care Access Research SOP .   Follows SOPs/GCP precisely; completes documentation accurately.  Demonstrates empathy; follows patient privacy and safety protocols.  Complete visit procedures in accordance with protocol.   Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.   Receives structured mentorship; participates in shadowing and skills validation.  Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.   Low complexity; stable protocols with limited procedures and minimal IP handling.  Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.   Prioritize activities with specific regard to protocol timelines   Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.   Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.   Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  Documentation Record data legibly and enter in real time on paper or e-source documents   Accurately record study medication inventory, medication dispensation, and patient compliance.   Resolve data management queries and correct source data within spon...