The Center for Clinical Research Management (CCRM) Operations team provides oversight of clinical trial coordination including protocol implementation, subject recruitment, study management as well as onboarding and training of clinical research staff.
The Operations team is responsible for:
- Establishing policies and procedures
- Overseeing clinical research coordinating staff for supported groups
- Maintaining a comprehensive 12-week onboarding curriculum for new clinical research staff
- Providing focused management/development of clinical trials
- Ensuring timely activation of clinical trials
- Quality Assurance
- Assisting investigators with recruitment and consenting
- Serving as liaison to investigator, investigational pharmacy, correlative lab and clinical operations to ensure protocol compliance
- Providing protocol and other document feedback from an operational standpoint
- Assisting with protocol review and informed consent development
- Coordinating ancillary departments
- Providing guidance on adverse event report form completion as needed in conjunction with the CCRM Regulatory team
- Participating in internal and external audits including assistance with preparing for audits
- Monitoring all regulations and guidance to identify and implement any changes to operational processes or best practices
- Managing data integrity for the OnCore database