The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials.
Requirements
High School Diploma or GED and five years of clinical research experience.
Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.
Or a licensed as a practical nurse (LPN) and two years clinical research experience.
Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.
Or a Master's degree, MD or PhD in a scientific, health related or business administration program.
Responsibilities
Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.
Provides guidance to less experienced staff.
Interfaces with research participants, determines eligibility and consents study participants according to protocol.
Approves orders for supplies and equipment maintenance.
Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
Supervises collection of study specimens and processing.
Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.
Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.
Prepares regulatory submissions.
With appropriate credentialing and training may perform phlebotomy or diagnostics.
Performs related approved responsibilities as required.