Clinical Data Specialist III

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

 

Works with clinical research team members, including PIs, study coordinators, data analysts, and biostatisticians, to ensure that all aspects of the data management process are executed efficiently and accurately. Leads day-to-day operations of managing clinical research data for study teams at the Duke University School of Nursing (DUSON) supporting our shared goal of scientific integrity and the rigor and reproducibility of our research; performs a variety of complex duties involved in planning, oversight, and regulation of the collection, compilation and documentation of clinical research data and metadata to help safeguard data accuracy; data preparation for analysis; completeness and compliance with regulatory requirements, and facilitates researchers in navigating the clinical research environment. Collaborates within DUSON and across campus with other data-focused units of research and technology. Supports adherence to Duke Data Management Policy, provides guidance based on CRU and institutional best practices, and ensures all aspects of the data management lifecycle meet Duke Data Security requirements. Oversees the work of other clinical research staff if needed.

 

This position is responsible to the Director of the Health Statistics and Data Science Core at DUSON.

 

WORK PERFORMED

 

Research Operations

 

• In collaboration with the Duke Office of Scientific Integrity, serves as an expert resource to study teams on design, implementation and adherence to data management plans, design of case report forms, developing data entry guidelines and standards and overseeing data quality control processes. Ensures adherence to internal and regulatory institutional policies and processes, and study-level documentation.
• Oversees and provides support to study teams for the documentation (e.g., involving datasets from multiple sources, big data, or non-standardized data) and harmonization of discrete, potentially cross-domain datasets for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Plans and implements electronic data capture systems to facilitate efficient data collection.
• Clinical data managers also collaborate with study and research teams to address data-related issues promptly and generate accurate data summaries and reports for clinical study reports.
• Develops, oversees adherence, and trains in the use and development of standard operating procedures (SOPs) across study teams and works towards helping study teams adhere to regulatory guidelines and SOPs to ensure data integrity and compliance throughout the research lifecycle.
• Effectively facilitates or leads, if needed, team meetings to achieve objectives. Ensures effective communication across multiple study teams.

 

Safety and Ethics

 

• Provides oversight and training to multiple study teams who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies, such as the NIH Data Management and Sharing Plan.

 

Data

 

• Under direct supervision from Biostatisticians and PIs, may perform basic analyses on a variety of data formats. May provide mentorship or education to others on programs and tools for data cleaning and analysis.
• For multiple study teams, selects data capture methods and discusses the advantages and disadvantages of each.
• Implements data capture methods at the multiple levels of research units. Independently designs appropriate programs/algorithms to collect data according to protocol. Provides training and oversight into the creation of the data collection programs/algorithms using appropria