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.
Service includes: 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, and facilitating research file and data storage. This is a fee for service core facility.
Service includes: 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 and coordinating shipment of research specimens; preparation and submission of amendments, renewals, and other study documents; facilitating study monitoring visits; and completion of Case Report Forms (CRFs)/eCRFs.
Service includes: preparation and submission of Institutional Review Board materials, submission of Harvard Catalyst Human Research Center application materials, coordination of site initiation visits, regulatory binder creation and organization, and development of data collection forms/source documents.