Overview of Services
Provides a pool of experienced research staff to assist with clinical start-up, implementation, and closeout. This resource alleviates the administrative burden associated with training and managing research staff and allows investigators to pay only for the amount of effort required.
Startup
- Assistance with budget preparation and negotiation
- Office of Grants and Contracts interaction
- OnCore management
IRB & Regulatory
- Creation and submission of initial applications, amendments, and continuing reviews for CoMIRB, WIRB, CIRB
- Informed Consent form and subject recruitment materials development
- Preparation and submission of regulatory documents (e.g. 1572, IND, IDE, Financial Disclosure Forms, CVs, etc.)
- Creation and maintenance of Regulatory Binders
- Preparing and maintaining clinicaltrials.gov submissions
- Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
Clinical Coordination
- Subject recruitment, prescreening and scheduling
- Obtain Informed Consent (following process mandated by Sponsor/PI)
- Data collection
- CRF completion/Data entry into local or external databases
- Financial tracking and invoicing
- Complete study visits and perform/assist with required procedures
- AE and SAE reporting
- Act as liaison for all subject-related communications with PI/study team
- Schedule and implement monitoring visits
- Prepare for and support for audits/reviews
Leadership
Kristen House | Core Administrator
Erin McDonagh; Program Director, Clinical Research Support Team
Location and hours of operation
| Hours |
Location |
|
Monday - Friday
8am - 5pm
|
Anschutz Medical Campus
University of Colorado Denver
|
Links and Resources
Welcome!
