Director of Research Operations, Manager of Research Operations, Sr. Regulatory Operations Specialist, Regulatory Documentation Specialist, and Research Grants and Contracts Specialist.
Key Support Services:
Guidance in study design, contract review, budget review, regulatory review, document preparation and IRB submission.
Are you interested in conducting a clinical trial?
If you are interested in conducting a clinical trial within the Centura Health system, please contact the Director of Research Operations:
Study Start-Up Activities
- Legal review of research-related contracts/agreements
- Financial review of study budgets, as applicable
- Medicare Coverage Analysis, as indicated
- Regulatory preparation, and coordination of IRB submission including required training in human subject protections by all key personnel
Operationalizing the Study
- Screening, recruiting, and enrolling study subjects
- Manage subject visits
- Perform study procedures
- Manage subject data reporting
- Ongoing study finance management
- Identification and reporting of adverse events
- Participate in audits and study monitor visits
- Build studies in Epic linking study visits to the subject in the EHR
Research Electronic Data Capture (REDCap)
Research Electronic Data Capture (REDCap) is available to research clinicians throughout Centura, including health professionals within and affiliated with a Centura entity. REDCap, created by Vanderbilt University in 2014, is supported by the REDCap Consortium to primarily facilitate Institutional Review Board-approved (IRB) clinical research.
The web application is licensed to Centura and is a go-to method for supporting both single and multi-site research studies. REDCap is utilized for building and managing online surveys and databases. The features include:
- Secure full user authentication, user rights, data validation, secure data storage, de-identification and audit trail ability.
- Data downloads to common statistical application (SPSS, SAS, Strata and .csv) formats. Users may also import data through Microsoft Excel.
- Advanced features include file uploading, auto-validation, branching logic, calculated fields, signature, Dynamic Query (SQL).
There may be projects not research related where REDCap is an appropriate platform for data acquisition and management.
To request access or for more information on REDCAP, please contact our Research Operations department: