Clinical Research Coordinator 1

Department

BSD CCC - Network Oncology Research Support

About the Department

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 190 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary

The Clinical Research Coordinator 1 provides support to the faculty of the Section of Hematology/Oncology within the Biological Sciences Division. The CRC1 will be involved in multiple research trials types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section.

The job performs routine assignments related to the documentation and reporting of basic clinical studies. Supports decisions that impact clinical research conducted across the University.

Responsibilities

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

• Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

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

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

• Prepares and maintains protocol submissions and revisions.

• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.

• Performs assessments at visits and monitors for adverse events.

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

• May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Accountable for all tasks in basic clinical studies.

• Assists with various professional, organizational, and operational tasks under direct supervision

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

• 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 < 2 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• Bachelor’s Degree or experience greater than 2 years in the related field.

Experience:

• Knowledge of medical terminology/environment.

• Relevant experience greater than 2 years.

Preferred Competencies