JOB SUMMARY

The Clinical Research Coordinator 2 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines.

• Reviews new protocols and other materials provided by Study Sponsors, and provides input to the PIs and clinical managers, as applicable, regarding clinical and research issues in order to establish financial and clinical feasibility.
• Coordinates the implementation of various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors, providing in-service education for healthcare professionals, and working with Pharmacy to ensure a smooth project flow.
• Reports to the Institutional Review Board (IRB), completing IRB review reports and assisting with drug accountability.
• Develops research study budgets for new clinical trials and assists in the completion of all applicable research billing compliance procedures.
• Coordinates study-monitoring visits. Completes and submits monthly invoices for applicable patient care charges covered by funded research studies.
• Participates in data testing, writing and submitting manuscripts and abstracts for publication, as appropriate.
• Develops, implements and administers Clinical Research policies and procedures.
• Unites with quality audits.