Prog Mgr, Research Systems
Overview
The role will interact with internal research staff, and REDCap Administration to lead, gather requirements, create documentation, and perform testing in support of the 21 Code of Federal Regulations (CFR) Part 11 compliant REDCap environment. This position provides end user support with 21 CFR Part 11 REDCap projects that have been designed and created for use by research staff in collaboration with REDCap Administrator.
Responsibilities
- Work closely with REDCap administration staff, Clinical Trial Management office staff, and other stakeholders to implement and maintain a validated 21 CFR Part 11 Compliant REDCap environment following the available Implementation Guide and REDCap Regulatory & Software Validation Committee (RSVC) process.
- Lead the effort of establishing, maintaining, and monitoring the validated 21 CFR Part 11 compliant REDCap environment using project management processes.
- Oversee all aspects of implementation including project scope, schedule, resource, risks, and overall management to ensure and drive successful delivery in collaboration with other stakeholders.
- Determine and document the steps, processes and workflows involved.
- Develop the required protocol/study level business SOPs (standard operating procedure) and other needed documentation such as Data Management Plan, Performance Qualifications, etc.
- Work with validation vendor/resources as needed to ensure system and process validation.
- Develop and provide training to research staff on 21 CFR Part 11 compliance.
- Support Research staff with their project builds, training, and use of REDCap for 21 CFR Part 11 projects collaborating with REDCap administration, study teams, and stakeholders to ensure compliance.
- Work with study teams on performing user acceptance testing (UAT) to confirm project meets requirements including verifying secure data exports, etc. and ensure proper documentation of testing.
- Consult with research staff on best practices when developing a 21 CFR Part 11 REDCap projects.
- Assist research end users in troubleshooting 21 CFR Part 11 REDCap projects, collaborating with REDCap Administration as needed
- Stay current on REDCap features and functionality through training and/or self-education.
- Lead or assist with special project work as assigned.
- Qualifications
- Master's Degree Computer Science, Health Informatics, Information Systems, Project Management, Business Administration, Project Management, Nursing or related degrees/field of study. and 3-5 years experience or
- Bachelor's Degree Computer Science, Health Informatics, Information Systems, Project Management, Business Administration, Nursing, or related degrees/field of study. and 5-7 years experience
Remote Work/Work from Home
This position is entirely remote or work-from-home. The person hired must live in the Kansas City metro area and may attend on-site meetings, as scheduled.
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