CLINICAL DATA MANAGER

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes;  applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Under supervision, prepares for study monitoring and audit visits. Under supervision, collects information from sources including the EHR to assist study team in determining eligibility. Follows SOPs. Assists with maintenance of study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Participates in study team meetings.

Ethics:
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:
Under direct supervision from Biostatistician and PI 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. Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Maintains study-level documentation for all studies, including those that are complex in nature (e.g., involving datasets from multiple sources, big data, or non-standardized data). Provides oversight and training and lends expertise to multiple study teams. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Documents and maintains documentation to facilitate data sharing during publication or study closeout. Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. Under supervision, performs de-identification on allowable data to Safe Harbor standards. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan.  Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Learns and uses new technology when required. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. Under supervision, executes predetermined testing scripts after the completion of a build, or following any project changes or system upgrades.

Science:
Demonstrates and applies a basic understanding of open science practices and the FAIR data principals. Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management:
Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows.

Leadership:
Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary  to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates with other study personnel as required for study implementation and routine problem resolution.