Clinical Research Coordinator B (Department of Endocrinology,Diabetes and Metabolism)

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Posted Job Title

Clinical Research Coordinator B (Department of Endocrinology,Diabetes and Metabolism)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position will assist in the management of clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study recruitment and coordination/ conduction of study events.

Job Description

Job Responsibilities

• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation

• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies

• Coordinate the administration of the related medications including obtaining orders, scheduling administration dates, monitoring subjects for post-administration adverse events or reactions

• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures

• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception)

• Manage collection of data from source documents pertaining to study visits and