REDCap Cloud Study Specialist

Job Title:

REDCap Cloud Study Specialist

Job Description

The REDCap Cloud Study Specialist designs, builds, and validates clinical study databases and electronic data capture solutions that support a high-profile NIH clinical research program. This role translates clinical trial protocols into robust technical configurations within REDCap Cloud and other EDC platforms, ensuring data integrity, regulatory compliance, and smooth system integrations. The specialist collaborates closely with Agile teams and end users to configure studies, perform user acceptance testing, and provide technical support for clinical research operations.

Responsibilities

+ Design and build clinical studies and databases in the REDCap Cloud platform, including electronic Case Report Forms (eCRFs), surveys, and related clinical data structures.

+ Configure and manage electronic data capture (EDC) solutions, including ePRO and other clinical data collection tools, based on study protocols and requirements.

+ Program complex validation rules, edit checks, and data queries to ensure data quality, consistency, and regulatory compliance.

+ Translate clinical trial protocols and study requirements into detailed technical system specifications and configurations.

+ Perform user acceptance testing (UAT) for study builds and system changes, documenting results and addressing issues identified during testing.

+ Execute validation activities and maintain thorough documentation to support compliance with 21 CFR Part 11, Good Clinical Practice (GCP), and internal quality standards.

+ Assist users and customers with configuration and usage questions related to REDCap Cloud and other EDC platforms, providing timely technical support and guidance.

+ Collaborate with Agile development teams to support the design, development, and implementation of clinical data management solutions.

+ Assist with data exports, reporting, and integration with statistical tools such as SAS, R, and SPSS to support analysis and reporting needs.

+ Support integrations with external systems as needed, ensuring data flows are accurate, secure, and aligned with study requirements.

+ Document system configurations, changes, workflows, and validation activities in a clear and compliant manner.

+ Contribute to continuous improvement of study build processes, configuration standards, and documentation practices.

Essential Skills

+ Bachelor's degree in life sciences, computer science, or a related field.

+ At least 3 years of study build experience with an Electronic Data Capture (EDC) platform such as REDCap, Medidata Rave, Veeva, or similar systems.

+ Hands-on experience designing and configuring eCRFs, surveys, and clinical databases in an EDC environment.

+ Proficiency with REDCap Cloud or comparable EDC platforms, including study setup, configuration, and maintenance.

+ Demonstrated ability to program complex validation rules, edit checks, and data queries to support high-quality clinical data.

+ Experience working with systems compliant with 21 CFR Part 11 and Good Clinical Practice (GCP).

+ Proven experience performing user acceptance testing (UAT) for clinical systems or study builds, including test planning and execution.

+ Strong skills in translating clinical trial protocols into detailed technical system requirements and configurations.

+ Ability to assist with data exports, reporting, and integration with statistical tools such as SAS, R, or SPSS.

+ Solid understanding of clinical data management processes and workflows in a regulated environment.

+ Strong problem-solving skills and attention to detail in a technical and compliance-focused setting.

+ Effective communication skills to collaborate with Agile teams, stakeholders, and end users.

Additional

Skills & Qualifications

+ Experience as a REDCap Cloud Study Builder or Systems Integration Specialist.

+ Background in configuring and validating electronic patient-reported outcomes (ePRO) solutions.

+ Familiarity with surveys and patient-facing data collection tools in clinical research.

+ Experience supporting integrations between EDC platforms and external systems or tools.

+ Exposure to large-scale or high-profile clinical research programs.

+ Interest in working on initiatives aligned with national clinical research priorities.

+ Ability to work effectively in Agile development environments and cross-functional teams.

Work Environment

This role operates in a hybrid work model, combining on-site and remote work to support flexibility and collaboration. The position typically requires three days per week on site and two days working from home, with remote days used at the employee's discretion in coordination with team needs. The on-site location offers free parking and is situated in Bethesda. The work environment centers on configuring and supporting REDCap Cloud and other EDC platforms, collaborating with Agile teams, and engaging with clinical research stakeholders involved in a well-funded, high-profile NIH program.

The role involves regular…