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
- 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
- Ongoing study finance management