Clinical Research Coordinator III

careaccess · Dalton, Georgia, United States · Georgia, United States

<div class="content-intro">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 <a href="http://www.careaccess.com/">www.CareAccess.com</a>.</div><h3>How This Role Makes a Difference</h3> <div> 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.  The CRC III is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites.  </div> <div> <h3>How You'll Make An Impact</h3> <div> <ul> <li>Patient Coordination  <ul> <li>Manages some of the sites most challenging therapeutic areas and study designs   </li> <li>High complexity; intensive assessments, multi‑arm trials, frequent sponsor interaction.  </li> <li>Champions balancing protocol needs with patient experience and safety across studies; models best practices.   </li> <li>Can operate as solo CRC onsite. </li> <li>Prescreen study candidates  </li> <li>Obtain informed consent per Care Access SOP </li> <li>Complete visit procedures in accordance with protocol.  </li> <li>Complete basic clinical procedures per protocol, such as blood draws, vital signs, ECGs, etc.  </li> <li>Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.  </li> <li>Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.  </li> <li>Prioritize activities with specific regard to protocol timelines  </li> <li>Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.  </li> <li>Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  </li> <li>Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  </li> </ul> </li> <li>Documentation  <ul> <li>Record data legibly and enter in real time on paper or e-source documents  </li> <li>Accurately record study medication inventory, medication dispensation, and patient compliance.  </li> <li>Resolve data management queries and correct source data within sponsor provided timelines  </li> <li>Assist regulatory personnel with completion and filing of regulatory documents.  </li> <li>Assist in the creation and review of source documents.  </li> </ul> </li> <li>Patient Recruitment  <ul> <li>Assist with planning and creation of appropriate recruitment materials.  </li> <li>Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.  </li> <li>Actively work with recruitment team in calling and recruiting subjects  </li> </ul> </li> <li>Site Support  <ul> <li>Primary point of contact for the site  </li> <li>Supports Key Sponsors and CROs  </li> <li>Responsible for mentoring and training CRAs and CRC I/CRC II to ensure complete understanding of Care Access

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