Liaison between the management, clinical operations, and the laboratory to ensure that all testing requirements are met. Ensuring compliance with all applicable regulations, including but not limited to, budget, data collection, and analysis
Participates in the development of a new EMR system for the recruitment Coordinator to ensure compliance with all applicable state and federal regulations.
Coordinates the collection of clinical trials, oversees the laboratory operations, and ensures that all aspects of patient care are met.
Assisting with the collection of data analysis for audit reports, and in collaboration with the clinical operations team to ensure that all the study facets are met.
Provides support and education to the clinical staff, including the collection of data, analysis of data, and audit preparation.
Develops and implements the clinical trial management Plan, including the collection of data, protocol development, and quality control analysis.
Clinical Research Coordinator
Performed laboratory packaging, shipping, and shipment of biological specimens. Processed and shipped blood samples. Managed study drug accountability.
Maintained patient records and files for study visits and regulatory documents. Ensured that all IRB submissions and approvals were obtained and signed off.
Works with the study team to ensure that trial is responsible for the study start up. Monitors and tracks all regulatory documents.
Responsible for the preparation of study documents for submission to the IRB. Ensure that all serious adverse events (SAEs) are reported in accordance with the protocol.
Assist the PI in the preparation of study documents for submission to the IRB. Ensure that all regulatory documents are submitted to the IRB.
Performed site visits, including but not limited to, monitoring of study data, source documentation, and query resolution.