Senior Clinical Research Coordinator - Duke University ...

School of Nursing Established in 1931, Duke University School of Nursing is among the top-ranked of the nation€™s nursing schools. The school is proud of its overarching commitment to educating the next generation of nurse leaders and advancing the roleof nurses and nursing in the transformation of health care and in the expansion of health equity. The School of Nursing has an inclusive and diverse community that supports the professional goals of its students, faculty, and staff as they pursue excellence. Comprised of 1,600 faculty, staff, instructors, and students, the Duke University School of Nursing, Duke University School of Medicine, and Duke University Health System are a part of Duke Health. The Duke University Health System is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a network of health services. It encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Occupational Summary This position will have oversight over a grouping of research studies at the SON and will be responsible for study operations which may include hiring/managing staff. This is a flexible position, with a focus on implementing study start up procedures for multiple teams and ensuring compliance with institutional policies and procedures. This position may serve as a study CRC when necessary. Supervisor This position reports directly to the Research Practice Manager. As a research staff member in the School of Nursing (SON) CRU, this position is directly accountable to the SON''s Research Practice Manager (RPM) for these specific responsibilities: a) appropriate human subjects and research training according to institutional standards; b) good clinical practice (including IRB submissions and renewals; protocol initiation; patient recruitment, screening, consent and enrollment; safety reporting; and study close-out); c) adherence to CRU standard operating procedures, institutional HRPP, and all applicable regulatory requirements. Essential duties: Operations: Recognizes when agreements are necessary within the research program and facilitates the process by coordinating with study teams and appropriate Duke offices. Serves as an expert resource to multiple study teams/research programs regarding regulatory and institutional policies and processes. Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Serves as an expert resource for multiple study teams/research programs for participant retention. Liaises with other resources at Duke to optimize retention rates. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Assists with study start up activities. Screens participants for all studies, including those that are complex in nature (e.g., procedural, and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping, and maintenance. Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies. Ethics: Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. Data: Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Predicts areas of vulnerability in data flow across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Oversees implementation of data flow plans across the research portfolio. Ensures that study teams are familiar with and using data flow plan resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant. Science: Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Uses expertise in research design to provide significant contribution to protocols or research proposals. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications. Study and Site Management: Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site/monitoring visits. Oversees use of systems and system reports to manage research participants'' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Oversees implementation of operational plans across research program, including at multiple sites. Develops and implements closeout procedures for multiple studies across multiple teams. Leadership: Encourages staff to take part in professional development opportunities. Keeps current with advances in the scientific area and considers the impact on the research program. Keeps self and team current with research updates by attending external offerings; applies learned material on the job. Plays key/leadership role on committees and workgroups. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study team''s adoption of change in their working environment. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication. Miscellaneous: Follow Duke procedures regarding requirements around SSN storage and payment processing. Perform other related and requested duties incidental to the work described herei Minimum Qualifications Education and Experience : Completion of an Associate''s degree and a minimum of six years of research experience Completion of a Bachelor''s degree and a minimum of four years of researchexperience. Completion of a Master''s degree and a minimum of 2 years of research experience. Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers). Knowledge of Duke policies and procedures, and skilled at using Duke research systems (iRIS, OnCore and MaestroCare). Strong regulatory skills preferred. Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual''s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Created: 2025-11-15