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The Clinical Research Coordinator Lead plans, organizes, leads, and performs comprehensive, advanced level clinical trial duties for multiple or complex clinical trials. Working under limited supervision, this position serves as team mentor and back-up role for the Clinical Research Manager, providing guidance and advice to the broader research team. |
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Coordinates multiple clinical trials simultaneously and trials with high complexity, managing and organizing various research activities efficiently, ensuring optimal use of resources and timely execution of research protocols. Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. - Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. Completes clinical tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. Serves as study coordinator for highly complex trials pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. Mentors and trains Clinical Research Coordinators I and Clinical Research Specialists I & II to ensure an effective and compliant team. Serves as back up to/supporting role for the Clinical Research Manager, assisting with HR support, financial support, budgeting/contracting support. Performs other duties as assigned. |
EDUCATION: |
Required: Bachelor's degree |
EXPERIENCE: |
Required: 6+ Years |
LICENSURE/CERTIFICATION/REGISTRY/LISTING: |
Required: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification |
Equal Opportunity Employer At Cone Health, we strive to create a welcoming atmosphere that celebrates a diverse and unique workforce. We believe in offering equal opportunities for employment to all applicants and employees, regardless of their race, religion, age, sex, sexual orientation, gender identity, veteran's status, ethnicity, national origin, disability, color, or any other characteristic protected by law. Our hiring and employment choices are based on each individual's qualifications, skills and performance. We believe that by embracing the diversity of our team, we can better serve our patients, communities and each other.
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