Clinical Research Coordinator A

University Overview

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The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Research Coordinator A

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

This position will assist in the management of multiple 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 coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.

Job Description

Job Responsibilities

• Conduct clinical investigation utilizing GCP, which includes possessing and demonstrating knowledge of federal regulations and guidance documents for the conduct of clinical studies involving human subject and their protection.

• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentation and maintaining regulatory binders through subject study completion.

• Coordinate and conduct human subject clinical study including:  subject recruitment; visit scheduling and facilitation; informed consent; case report form population; chart maintenance; data management. 

• Accurate and timely database inputting, management and analysis based upon source documentation.

• General organization, maintenance, ordering and stocking supplies, maintaining equipment required to conduct study. 

• Coordinate with team members in retrieval and provision of documentation required for IRB submission/renewals in accordance with guidelines; continuing review, modification, deviation, adverse events, etc.

• Conduction of intermittent telephone contact with potential and current study participants in fulfillment of protocol requirements. 

• Meticulous documentation and reporting of all study and recruitment procedures and human subject interactions ongoing throughout research study.

• Attendance at and active participation in weekly team meetings, responsive to Investigators and accurate in reporting throughout investigation.

• Perform additional duties as assigned.

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

This position is contingent upon funding