Classification Specifications - H.70
Assistant Clinical Research Coordinator - 9336
Clinical Research Coordinator - 9335
Senior Clinical Research Coordinator - 9334
Senior Clinical Research Coordinator Supervisor - 9329
Clinical Research Coordinator Supervisor - 9328

January 2005

Series Concept

Clinical Research Coordinators provide support, coordination and leadership for drug/device studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials, government-funded clinical research, and investigator-initiated clinical research (collectively referred to as "clinical research involving human subjects"). They ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.

Incumbents prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, coordinate their clinical treatment and follow-up care, and help facilitate their continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents; develop and ensure compliance with study protocols; and participate in the planning, development, and budgeting for clinical studies.

Class Concepts

Senior Clinical Research Coordinator

Positions at this level independently coordinate and are accountable for the overall administration and outcome of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower­ level clinical research coordinators and/or other support personnel.

Senior Clinical Research Coordinator Supervisor

Performs range of duties outlined in the Class Concepts for Senior Clinical Research Coordinator and, in addition, meets the HEERA requirements for designation as a supervisory employee.

Clinical Research Coordinator

Positions at this level independently or with general direction perform one or more of the functions described above at the fully operational journey level. This level will serve as the benchmark for this series.

Clinical Research Coordinator Supervisor

Performs range of duties outlined in the Class Concepts for Clinical Research Coordinator and, in addition, meets the HEERA requirements for designation as a supervisory employee.

Assistant Clinical Research Coordinator

Under full supervision, positions at this level perform entry-level duties related to the support and coordination of clinical studies. Incumbents may receive training intended to prepare them for journey-level work, and may advance to the next level in the series within two years.