Prog Mgr, Research Systems
Prog Mgr, Research Systems
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Thanks for your interest in Childrens Mercy!
Do you envision finding a meaningful role with an inclusive and compassionate team At Childrens Mercy we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference which is why we have been recognized by U.S. News & World Report as a top pediatric hospital for eleven consecutive years.
Childrens Mercy is in the heart of Kansas City a metro abounding in cultural experiences vibrant communities and thriving businesses. This is where our patients and families live work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in childrens health we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital.
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.
At Childrens Mercy we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve as well as our core values of kindness curiosity inclusion team and integrity.
Additionally its important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve as well as the Childrens Mercy staff we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles mumps rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus diphtheria acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines medical and/or religious exemptions can be further discussed with Human Resources.
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.
Skills
Clinical research experience with clinical research operations experience
Experience implementing projects or programs with a variety of assignments.
Experience building research REDCap projects of varying complexity.
Qualifications
- Masters 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
- Bachelors Degree Computer Science Health Informatics Information Systems Project Management Business Administration Nursing or related degrees/field of study. and 5-7 years experience
Benefits at Childrens Mercy
The benefits plans at Childrens Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families.
Learn more about Childrens Mercy benefits.
Starting Pay
Our pay ranges are market competitive. The pay range for this job begins at $37.71/hr but your offer will be determined based on your education and 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.
EEO Employer/Disabled/Vet
Childrens Mercy hires individuals based on their job skills expertise and ability to maintain professional relationships with fellow employees patients parents and visitors. A personal interview formal education and training previous work experience references and a criminal background investigation all are factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race color religion sex national origin age disability creed genetic information sexual orientation gender identity or expression ancestry or veteran status. A drug screen will be performed upon hire. Childrens Mercy is smoke and tobacco free.
Required Experience:
Manager
Employment Type
Unclear
