Overview
Manages the research data of a multi-year randomized controlled trial, designed to alter developmental origins of disease via reduction of prenatal stress exposure. This position interacts closely with multiple stakeholders within and outside of the study, including the scientific leads, operational sponsors, study participants, and other academic and clinical partners. The ideal candidate will have a demonstrated history of working independently with initiative and a strong sense of personal responsibility while maintaining a high standard managing complex data. Responsibilities include: Monitoring multiple systems to assure protocol adherence and data quality. Maintaining research data and preparing reports, preparing data files for analysis, and performing some independent statistical analysis of clinical research data for evaluation / process improvement purposes.
Responsibilities
Manages data capture, archival, curation and documentation for a complex clinical research study.
Develops and maintains systems for assuring adherence to study protocols and compliance with internal and external policies, standards, rules and regulations.
Identifies need for and coordinates participant follow up at each stage of the project.
Continuously ensures data quality and integrity by monitoring and validating study data as it is collected, and by maintaining reliable systems for data governance.
Maintains active surveillance of study operations to anticipate and proactively avoid fault points and barriers to study progress.
Performs foundational statistical analysis of clinical research data and works with study statistician to implement more complex statistical analyses as needed.
Works collaboratively as part of a multi-disciplinary team at Lurie Children’s and Northwestern University with academic and clinical partners as well as study participants.
Responds to support requests and general questions from study participants regarding data collection equipment, study protocols, research consents, etc.
Monitors recruitment and documentation of study participants in accordance with study protocols, often working in close collaboration with clinicians and other staff.
Promotes clinical research activities within the hospital and the community.
Other job functions as assigned.
Qualifications
- Bachelors degre in social or behavioral sciences, physical science, education, nursing or related health field is required. Master’s degree preferred.
- 1-2 years of experience working in a research setting preferred.
- Strong analytical, computational and organizational skills with consistent attention to detail. Strong customer service skills.
- Strong verbal and written communication skills in order to address diverse/large audiences.
- Demonstrated working knowledge of regulatory practices required.
- Proficient in Microsoft Word and PowerPoint, with advanced skills in Excel (or similar) for data curation, analysis and basic visualization.
- Knolwedge of / experience with collecting and manipulating data in REDCap and/or orther data capture software.
- Experience with database or statistical tools such as SQL, R, SASS or SPSS preferred.
