REDCap Cloud Study Builder & Systems Integration Specialist

Job Title:

REDCap Cloud Study Specialist

Job Description

The REDCap Cloud Study Specialist designs, builds, and validates clinical study databases and electronic case report forms in REDCap Cloud and other Electronic Data Capture (EDC) platforms to support a high-profile NIH clinical research program. This role translates clinical trial protocols into robust technical solutions, configures complex validation rules and edit checks, supports system integrations, and ensures that all study builds meet regulatory and quality standards.

The specialist collaborates closely with Agile teams and end users, provides technical support, and contributes to high-quality data collection and reporting across multiple clinical studies.

Responsibilities

* Design and build electronic Case Report Forms (eCRFs), surveys, and clinical databases in the REDCap Cloud platform and other EDC systems based on study protocols.

* Configure study environments, including complex validation rules, edit checks, and data queries to ensure accurate and complete data capture.

* Translate clinical trial protocols and study requirements into detailed technical system specifications for EDC, ePRO, and related study tools.

* Perform user acceptance testing (UAT) to validate system configurations, workflows, and integrations, and document test results and resolutions.

* Execute and maintain validation documentation to ensure systems comply with 21 CFR Part 11, Good Clinical Practice (GCP), and internal quality standards.

* Manage technical implementations for clinical trials, including updates, enhancements, and troubleshooting throughout the study lifecycle.

* Assist study teams and end users with configuration and usage questions, providing timely technical support and guidance.

* Collaborate with Agile development teams to support system development, enhancements, and implementation of new features or integrations.

* Assist with data exports and reporting, including preparing datasets and outputs for use with statistical tools such as SAS, R, and SPSS.

* Support integrations between REDCap Cloud and external systems as needed to enable efficient data flow and reporting.

* Document system configurations, changes, and workflows in a clear and organized manner to support audit readiness and knowledge sharing.

* Contribute to continuous improvement of study build processes, templates, and standards to increase efficiency and quality across projects.

Essential Skills

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

* Proven experience designing and configuring electronic Case Report Forms (eCRFs), surveys, and clinical databases for clinical trials.

* Strong proficiency in configuring complex validation rules, edit checks, and data queries within EDC platforms.

* Demonstrated ability to translate clinical trial protocols and requirements into detailed technical system configurations.

* Experience performing user acceptance testing (UAT) for clinical study systems, including test planning, execution, and documentation.

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

* Hands-on experience with REDCap or REDCap Cloud in a clinical research or clinical data management context.

* Ability to support data exports and reporting, including preparing datasets for statistical tools such as SAS, R, or SPSS.

* Strong technical problem-solving skills with the ability to troubleshoot configuration and integration issues.

* Effective communication skills to collaborate with cross-functional and Agile teams and support end users.

Additional

Skills & Qualifications

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

* Experience with ePRO (electronic patient-reported outcomes) systems and survey configuration within clinical studies.

* Background in clinical data management or clinical research operations.

* Familiarity with systems integration concepts for clinical research platforms.

* Ability to work effectively in a hybrid environment and manage priorities across multiple studies or projects.

* Strong documentation skills for recording system configurations, workflows, and validation activities.

Work Environment

This is a hybrid role that combines on-site collaboration with remote flexibility. The position is based in Bethesda and 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, providing convenient access to the facility. Work is performed in a professional office environment, collaborating with cross-functional and Agile teams and using modern clinical research technologies, including REDCap Cloud, other EDC platforms, and statistical tools such as SAS, R, and SPSS.

The role supports a well-funded, high-profile NIH clinical research program, offering…