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Duke University

Private research university in Durham, NC

Senior Regulatory Coordinator - Neurosurgery

Clinical Research OperationsUpdated on Nov 14
Full-timeDurham, NC, USA$70.7k - $112.9k /yr

About the Job

Requirements

  • An associate's degree is required. A bachelor's degree may substitute for two years of the required research experience.
  • At least six years of research experience is required. Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship program may substitute for one year of required experience.
  • Proficiency using Microsoft Office applications, web-based systems, and other research-related software applications is required.
  • Ability to manage multiple studies and priorities simultaneously while maintaining attention to detail is required.
  • Strong organizational, communication, and problem-solving skills are required.
  • Ability to work collaboratively with investigators, sponsors, and research staff is required.
  • Basic Life Support certification from the American Heart Association or a Duke-approved equivalent course is required.
  • Ability to maintain Duke and protocol-specific training and certification requirements is required.
  • Ability to work effectively in a fast-paced clinical research environment and comfort interacting with patients, healthcare providers, sponsors, monitors, and regulatory personnel are required.

Responsibilities

  • Coordinate complex clinical trials from study startup through closeout, including first-in-human brain and spine infusion drug and device studies involving pediatric and adult subjects.
  • Serve as an expert resource for Investigational New Drug submissions, assist junior staff in addressing FDA reviews or issues, and provide oversight and guidance to staff preparing FDA-required documents, annual reports, and amendments.
  • Direct multiple study teams in preparing for study monitoring and audit visits.
  • Collaborate with Principal Investigators, sponsors, and study teams to conduct clinical research studies.
  • Recognize when agreements such as CDAs, DUA/DTAs, and MTAs are needed and alert the appropriate parties.
  • Maintain study documentation, regulatory binders, and required research files for all studies.
  • Monitor protocol compliance and ensure adherence to institutional policies, federal regulations, and Good Clinical Practice guidelines.
  • Document and report adverse events and protocol deviations in a timely manner.
  • Support development of Conflict of Interest materials, Data Safety Monitoring Plans, and Research Data Security Plans.
  • Enter, review, and maintain accurate regulatory data in Electronic Data Capture systems, eReg systems, or other requested electronic systems.
  • Identify and resolve discrepancies and documentation issues.
  • Support study budget management, financial milestone tracking, and study closeout activities.
  • Coordinate with financial teams to ensure timely processing of study startup agreements, study-related expenses, and billing reviews.
  • Serve as a data-corrections, queries, and quality-assurance expert resource within the Clinical Research Unit, department, or division, including liaising with and understanding other related Duke resources.
  • Ensure multiple study teams appropriately document adverse-event information.
  • Provide oversight and training to multiple study teams developing and submitting documentation for Institutional Review Board review and preparing documents for regulatory and safety reporting to sponsors and other agencies.
  • Apply professional guidelines and codes of ethics related to clinical research.
  • Independently develop elements of research protocols for complex investigator-initiated studies across multiple Principal Investigators or study teams, using scientific proposals from the Principal Investigator.
  • Use research-design expertise to make significant contributions to protocols or research proposals.
  • Independently conduct literature searches or reviews and make significant contributions or provide leadership on accepted, peer-reviewed publications or conference presentations.
  • Serve as a primary liaison between sponsors, investigators, research staff, and contract research organizations.
  • Facilitate and lead meetings, committees, task forces, and departmental initiatives.
  • Mentor colleagues and serve as a resource for research best practices.
  • Train others to communicate effectively within teams and facilitate resolution of team or communication issues.
  • Pursue ongoing professional development.

Desired Qualifications

  • Regulatory research experience is preferred.
  • Experience with Duke and external Institutional Review Boards is preferred.
  • Research-related education, training, or certification is preferred.
  • Experience working with investigational products and complex clinical trials, and collaborating with the Duke Office of Regulatory Affairs and Quality, the U.S. Food and Drug Administration, the National Institutes of Health, and other regulatory agencies is preferred.
  • Experience developing informed consents, protocols, and supporting documents, and performing regulatory compliance activities is preferred.
  • Ability to handle study regulatory requirements, including Delegation of Authority logs, training logs, approval letters, standard operating procedures, adverse-event reporting, and budget and contract support, is preferred.
  • Familiarity with conducting internal monitoring under the Duke Clinical Quality Management Program policy, preparing for external monitoring visits, and supporting study initiation and closeout visits is preferred.

About the Company

Duke University

Private research university in Durham, NC

Duke University is a research university offering undergraduate, graduate, and professional education alongside interdisciplinary research and health care.

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