Clinical Research Coordinator I - RI Behav Trials Off

Overview

The Behavioral Trials Office (BTO) works with investigators and research teams to support our mission of providing efficient coordination of diverse behaviorally-focused clinical research, including behavioral intervention trials and observational research. Our work spans a variety of pediatric departments and developmental stages. This specific position would work primarily with endocrinology research.

Job Description

Summary: The Clinical Research Coordinator I manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.

Job Description

Essential Functions: Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate. Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures. Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours. Completes screening sheets and recruitment logs. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection. Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I. Adheres to departmental quality control guidelines. Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits. Maintains regulatory binder and documents. Education Requirement: Associates degree, STNA, PCA, LPN, MA or equivalent work-related experience required. BA/BS preferred. Licensure Requirement: (not specified) Certifications: Ability to obtain CRA/CRC certification in a timely manner.

Skills

Understanding of medical terminology and clinical research preferred. Working knowledge of PCs and word processing and data management software Demonstrated analytical skills with accuracy and attention to detail. Excellent verbal and written communication skills. Goal-oriented and self-directive Strong organizational and interpersonal skills. Ability to actively participate as a team player.