Clinical Research Coordinator II

Department

BSD MED - Endocrinology - Vokes Research Staff

About the Department

The Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism is a national leader in research leading to the development of new insights in the treatment of endocrine diseases and disorders. Work in the areas of diabetes, thyroid and sleep disorders has been greatly advanced by The University of Chicago endocrinology faculty. Our research activities are supported by a number of different sources including the National Institute of Health (NIH) and non-federal granting agencies. The Section is home to one of 16 NIH funded Diabetes Research and Training Centers. Over the years, several members of the Endocrine faculty have led investigations that resulted in significant discoveries in the areas of diabetes, thyroid and sleep disorders.

Job Summary

The Clinical Research Coordinator II works under the general direction of the PI within the Section of Endocrinology in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study.

The job provides technical support activities related to documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. By performing these duties with limited supervision and/or guidance, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Responsibilities

• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• Recruit and interview potential study patients with guidance from PI and other clinical research staff.

• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.

• Performs assessments at visits and monitors for adverse events.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.

• Ensures compliance with federal regulations and institutional policies. Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• May prepare and maintain protocol submissions and revisions.

• May assist in the training of new or backup coordinators.

• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.

• Accountable for all tasks in moderately complex clinical studies.

• Performs other related work as needed.

Minimum Qualifications

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