Participates in or leads day-to-day clinical research data operations conducted by Principal Investigator(s) within the Leukemia Clinical Research Team (CRT) as part of the Hematologic Malignancies and Cellular Therapies (HMCT) research groups within Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (CRU); performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Qualifications Required At This Level

Education/Training

Completion of an Associate's degree.

Experience

Work requires a minimum of two years of relevant data experience. A Bachelor's degree may substitute for two years required experience.

Preferences

Preferred skills include excellent communication skills, organization, time management, and can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

In-dept knowledge and expertise in Phase 1/2 clinical trials eCRF platforms (iMedidata Rave, Informs, Zelta, etc); to include Central Imaging platforms (Clario, Judi/AG Mednet, Calyx Ambra, etc). Experience with overseeing data management for large oncology portfolio with multiple industry sponsors that utilize a variety of data capture systems.

Ability to interpret, evaluate, and explain common procedures/processes as they relate to Hematologic Malignancies, Cellular Therapy, ABMT clinical research trials.

Ability to understand, devise, and revise methods needed to assist with overall research support.

Bachelor's Degree is strongly preferred.

Be Bold.

Operations, Study and Site Management - 30% Effort

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. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Develops or helps develop SOPs. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Participates in study team meetings.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

Demonstrates a basic understanding of the elements of research study designs.

Data - 50% Effort

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. 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. Demonstrates and applies open science practices and the FAIR data principals. Prepares data for deposit in repositories following publication or study closeout. Locates and follows repository-specific requirements to submit study data for sharing. May draft data sharing plans for clinical studies that ensure that data and documentation will support re-use. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.

Leadership & Professionalism - 10% Effort

Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. 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 effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Safety & Ethics - 10% Effort

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

Type of Research:

Ph1-3 HMCT studies, primarily Leukemia.

And other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/