7 years or more Research experience – Required
Must be willing to Float – Required
Bachelor’s Degree (or higher) – Required
Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) is required.
Current certificate of Human Subjects Protection and Good Clinical Practice training required.
Minimum 7 years of experience conducting clinical trials required; worked as primary research coordinator for at least 20 drug or device trials.
Minimum 7 years of experience interacting with patients in a healthcare setting required.
Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP, and GCP requirements required.
Experience in implementation of research protocols and clinical trials processes required
Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
Experience training staff and/or investigators on clinical trial processes and improvement techniques preferred.
Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
Experience with Microsoft Office software required.
Knowledge of medical terminology is required.
Lab processing experience required.

Clinical Research Coordinator

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