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CLINICAL RESEARCH COORDINATOR, SR

$69.36k - $110.66k

Duke University

Duke University Department of Obstetrics and Gynecology is hiring a Senior Clinical Research Coordinator for its Urogynecology division. The role focuses on coordinating NIH‑funded and industry‑funded trials in pelvic floor disorders. This in‑person position requires rotating between the Durham and Raleigh clinical offices. Minimum Requirements Associate’s degree required; a Bachelor’s degree with 2 additional years of experience can substitute. Minimum six years of research experience. Position Description Operations Identify necessary agreements (MTAs, CDAs, DUAs, etc.) and alert appropriate parties. Serve as an expert resource on regulatory and institutional policies for multiple study teams. Oversee management and documentation of investigational products. Design, implement, and optimize IP handling methods to prepare for monitoring and audit visits. Provide oversight and training on participant documentation for complex studies. Act as an expert resource on participant retention and recruitment strategy development. Train and supervise screening activities across study teams. Develop and enforce SOPs and standard procedures for specimen handling and inventory. Prepare for and lead research program meetings, ensuring effective communication and mentor staff. Ethics Ensure accurate identification and documentation of adverse events. Provide training on consent processes for all study types. Develop consent plans and oversee IRB documentation submissions. Prepare and submit regulatory and safety reporting documents to sponsors. Data Enter, collect, and validate research data, developing tools as needed. Ensure data accuracy, identify quality trends, and report issues. Maintain data security and provenance; detect and address vulnerabilities. Create progress reports and visualizations for PIs and stakeholders. Science Assist with funding proposals and protocol development. Understand research study design fundamentals. Contribute to scientific publications and presentations; serve as an author. Study and Site Management Mentor and train staff on sponsor and CRO communication. Manage participant calendars, financial milestones, and study visits using the clinical research management system. Maintain up‑to‑date protocol information and feasibility assessments. Oversee resources, including staff, supplies, and equipment. Manage study budgets and ensure compliance with institutional policies. Implement operational plans and close‑out procedures across teams. Leadership Encourage professional development and keep current with research updates. Serve on internal and external committees and workgroups. Navigate clinical research processes and demonstrate interpersonal skills. Develop and implement solutions within existing structures. Lead change adoption among study teams and communicate effectively across all levels. Anticipated Pay Range Duke University offers an annual base salary range of USD $69,362.00 to USD $110,658.00. Benefits Duke provides comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs. Learn more at Equal Opportunity Employer Duke is an Equal Opportunity Employer committed to employment opportunity without regard to age, color, disability, gender or gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy‑related conditions), sexual orientation, or military status. Essential Physical Job Functions Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodations can be requested with Duke Access and Accommodations Services (email: View email address on click.appcast.io; phone: View phone number on click.appcast.io). Locations Nearest Major Market: Durham Nearest Secondary Market: Raleigh Commitment to Diversity Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. All members are expected to uphold these values, ensuring everyone feels secure, respected, and heard. #J-18808-Ljbffr Duke University

Vacancy posted 5 days ago
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