Clinical Research Coordinator 1

JOB SUMMARY

The Clinical Research Coordinator 1 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. This position will learn to assist Principal Investigators on more complex studies and seek guidance from more senior roles when needed.

• Implements various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors.
• Creates, facilitates, and/or executes a variety of different project workflows based on the needs of the clinical trial protocol. Examples of workflows include, providing in-service education for healthcare professionals and working with Pharmacy to ensure a smooth project flow.
• Ensures that appropriate billing or charging mechanisms are in place for research charges related to research studies. Requires familiarity with research study budgets and provides feedback on budgets for new clinical trials.
• Performs research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
• Partners and coordinates with regulatory compliance including preparing Institutional Review Board (IRB) materials for approval of protocol amendments and submitting Investigational New Drug (IND) Safety forms. Ensures that all study documents are complete and that records are retained per federal, state and institutional standards.
• Obtains knowledge of departmental functions through reading literature, attending workshops, seminars and conferences and participating in professional organizations.
• Conducts and coordinates study-monitoring visits. Conducts audits and quality checks of research studies to check the accuracy, integrity and consistency of research studies.