Clinical Research Coordinator I

Department

BSD NSU - Research

About the Department

Neurosurgeons at UChicago Medicine are devoted to patient care, research, and teaching. These experts in the Department of Neurological Surgery offer the full spectrum of neurosurgical services for children and adults with brain diseases including aggressive brain tumors, back and spine degenerative diseases, epilepsy, Parkinson’s disease, and stroke. Our surgeons are truly at the forefront of neurosurgical care, utilizing the most advanced and sophisticated technologies and techniques to treat diseases of the brain and spine. Our expertise goes beyond that of delivering the best medical care; research is an integral part of our mission. With significant funding from the NIH in both bench and translational research, our staff and faculty are actively investigating complex conditions that affect the central nervous system, including cancer stem cell theory and aggressive brain cancers as well as the mechanisms behind cerebrovascular anomalies. This work serves as the groundwork for many new applications in neurosurgery, which will benefit patients for many years to come.

Job Summary

This position performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the Department of Neurological Surgery.

Responsibilities

• Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.

• Plans and coordinates subjects’ schedules for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

• Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques.

• Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.

• Organizes and actively participates in site visits from sponsors and other relevant study meetings.

• Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and facilitates the exchange of data across projects and organizations.

• Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

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

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.

• Analyzes protocols and advises treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Accountable for all tasks in basic clinical studies.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through &l