Clinical Research Manager

About this role

Department BSD CCC - Network Oncology Research About the Department The University of Chicago Medicine 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 funds ten Shared Resources. The Comprehensive Cancer Center comprises over 200 faculty members from twenty departments, with members currently being awarded over $51million in total direct costs in peer-reviewed cancer research grants, and $24 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, marketing andcommunications, fundraising, data analytics, clinical trials management, and community outreach and engagement.

The UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with more than 450 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 130 new trials each year and accrues approximately 800 participants to therapeutic trials each year. Job Summary The Network Clinical Research Manager (Manager) is a specialized research professional who is responsible for the direction of a program or a research office. The Manager works closely with the Director of Network Research Operations on long-range plans for network sites. While the Principal Investigator (PI) is primarily responsible for the overall design and conduct of the clinical trials in the network, the Manager collaborates with the PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as an expert. The Manager ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.

The Manager may write articles, reports and manuscripts and/or present research findings at meetings/conferences. By performing these duties, the Manager works with the PI, department, sponsor, and institution to provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Responsibilities Research Conduct/Study Management: • Responsible for the direction of a program or research office.

• Conducts research in the area of expertise.

• Collaborates with other researchers on long-range plans for research projects.

• Oversees the development of research projects.

• Ensures research projects progress according to plan.

• Investigates, modifies, and applies new procedures, techniques, or technological applications.

• Establishes goals and operating procedures, practices, and guidelines.

• Establishes, monitors, and controls project budgets.

• In collaboration with senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as an expert in a specialized area.

• Prepares grant/funding applications.

• Manages financial, personnel, planning, compliance, and other administrative aspects of research project(s).

Data Management: • Oversees activities related to data collection and analysis.

• Coordinates the conduct of the study from screening through to completion, including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Protects patient and data confidentiality by ensuring the security of research data and personal health information.

Regulatory: • Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives, and mandates.

• Understands 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.

• Understands the federal research regulations and identifies the federal research organizations’ role in regulating human research participation.

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

• Writes articles, reports, and manuscripts and presents research findings at meetings and/or conferences.

• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.

• Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.

• 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 7+ years of work experience in a related job discipline. Certifications: ---

Preferred Qualifications

Experience: • Supervisory

Similar jobs

• Clinical Research Manager — University of Wisconsin-Madison · Remote
• Clinical Research Manager — Envista · Brea, California, United States | Pomona, California, United States
• Clinical Research Project Manager — University of Chicago · Chicago, IL
• Senior Clinical Research Manager — BeiGene · Remote
• Clinical Research Leader — Johnson & Johnson · Remote
• Clinical Research Manager - Hematology and Oncology — University of Chicago · Chicago, IL
• Clinical Research Specialist — Medtronic · Mounds View, Minnesota, United States
• Clinical Researcher — Ceribell · Sunnyvale, CA