Research Operations
The Research Operations Core provides key services critical to the implementation and execution of clinical research studies at Johns Hopkins All Children's Hospital:
- Overall clinical research coordination including study start-up, IRB submission, maintenance of regulatory documents, participant screening and recruitment, informed consent, data collection, and adverse event monitoring and reporting
- Clinical unit-based research nursing to maximize recruitment and adverse event monitoring as well as collection of biological samples and administration of investigational agents
- Feasibility and operational needs assessment to determine individual study needs thereby accelerating the time from study start-up to first patient in
- Serve as Clinical Coordinating Center (CCC) and provide project management of multi-center, investigator-initiated studies
Our clinical research team has worked on a wide variety of studies including:
- Phase I - IV
- Investigational New Drugs (INDs)
- Investigational Device Exemptions (IDEs)
- Industry sponsored
- Investigator-initiated
- Consortium/Network
Our experienced team of Clinical Research Coordinators (CRCs) and Clinical Unit Based Research Nurses (CUBRNs) have expertise and certifications in many of the following therapeutic areas:
- Cardiology
- Cardiovascular surgery
- Neurosurgery
- Neurology
- Neonatology
- Hematology
- Oncology
- Blood & marrow transplantation
- Infectious disease
- Pulmonology
- Endocrinology
- General surgery
- Emergency medicine
In addition, our CRCs and CUBRNs have extensive research training and all eligible staff are Certified Clinical Research Professionals (CCRP) through the Society of Clinical Research Associates (SoCRA).
For additional information about the Research Operations Core, please contact:
Kyle Hawkins, MS, MBA
Director, Research Operations
Johns Hopkins All Children's Hospital
Institute for Clinical and Translational Research
501 6th Avenue South, Dept. 6550087517
St. Petersburg, FL 33701
P 727-767-72460 | F 727-767-6949
[email protected]