Partially funded through Harvard Catalyst, the Clinical Research Coordinator Core is available to support and collaborate with investigators and their research teams in all phases of clinical research, providing services that include assisting with the organization, implementation and completion of clinical research studies.
Study Start Up
- Preparation and submission of Institutional Review Board materials such as:
- Initial application
- Informed Consent forms
- Subject recruitment materials
- Submission of Harvard Catalyst Human Research Center application materials
- Coordination of site initiation visits
- Regulatory binder creation and organization
- Development of data collection forms/source documents
- Research participant recruitment and screening
- Assistance with determining study eligibility
- Assistance with the informed consent process
- Scheduling research procedures
- Facilitating research visits and assistance with data collection at study visits
- Sample processing & coordinating shipment of research specimens
- Preparation and submission of amendments, renewals, and other study documents
- Facilitating study monitoring visits
- Completion of Case Report Forms (CRFs)/eCRFs
- Coordination of study closeout visits
- Verifying that studies meet IRB standards for study closure
- Preparing and submitting IRB and other committee closure notification
- Performing data resolution for data analysis
- Facilitating research file and data storage
The Clinical Research Coordinator Core is a fee for service core facility. The CRC Core manager and the investigator will meet at the start of the study to determine the approximate time needed for a given project. Fees vary based on whether the project is investigator-initiated or industry-initiated. Limited pro bono support is available for junior investigators conducting investigator-initiated studies and for investigators who have received a Harvard Catalyst pilot grant.
Location and Hours of Operation
The Clinical Research Coordinator Core is located in the Clinical Research Center (East Campus/Gryzmish 8). Core staff are available Monday through Friday, during regular business hours. Extended and weekend hours may be available upon request.
Please contact us for more information or complete the core intake form.
Clinical Research Coordinator Core Intake Form
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