Senior Clinical Research Coordinator

Department
 

BSD CCC - Network Oncology Research

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 150 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 job independently manages the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. The Sr CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Sr. 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 studies.

Responsibilities

• Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data; process blood and urine specimens.

• Act as a liaison with medical staff, university departments, ancillary departments and/or network facilities.

• Serve as a resource person or act as a consultant within area of clinical expertise.

• Act as a leader within the department/unit through improving clinical research practice and serving as a resource.

• Maintain working knowledge of current protocols, and internal SOPs.

• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

• Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations. Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• Provide Investigators with guidance regarding protocol requirements. Maintain regulatory documentation.

• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.

• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

• Provide direct supervision of other CRC staff, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc. 

• Attend continuing education and training opportunities relevant to job duties. 

• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Acts as a resource on the ba