Classification Specifications - H.70
Assistant Clinical Research Coordinator - 9336
Clinical Research Coordinator - 9335
Senior Clinical Research Coordinator - 9334
Clinical Research Supervisor - 9333

February, 2001

Series Concept

Clinical Research Coordinators provide support, coordination and leadership for FDA regulated drug/device studies which 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.

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.

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.

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.

Clinical Research Supervisor

Positions at this level direct one or more clinical studies, supervise lower-level clinical research coordinators and/or other support personnel, may participate in clinical research policy and procedure development, and may provide leadership for a department-or division-wide clinical research program.

Certification or Licensure Requirements

Positions at the Senior Clinical Research Coordinator and Clinical Research Supervisor levels are required to possess certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Fair Labor Standards Act-Exemption Status

Assistant Clinical Research Coordinator, Clinical Research Coordinator and Senior Clinical Research Coordinator are non-exempt. Clinical Research Supervisor is exempt based on the FLSA guidelines for executive, professional or administrative exemption.

Supervisory Titles

Positions allocated to Clinical Research Supervisor must meet the criteria for supervision as defined in the Supplemental Guidelines for Supervisor Classes (SAM 12).

NOTE: Additional qualification requirements are approved for positions by the Human Resources Directors in accordance with the provisions of Personnel Policies for Staff Members 20 and 21.