Clinical Research Manager

About the role

The University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The UCCCC administers four established scientific programs and is supported by a Cancer Center Support Grant. The Comprehensive Cancer Center comprises over 200 faculty members from twenty departments, with members currently receiving over $51 million in peer-reviewed cancer research grants and $24 million in non-peer-reviewed grants and contracts. The UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with over 450 adult and pediatric therapeutic trials actively accruing patients.

Responsibilities

• 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.
• 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).
• Oversees activities related to data collection and analysis.
• Collaborates with senior research faculty and personnel to ensure protocol adherence.
• Protects patient and data confidentiality by ensuring the security of research data and personal health information.
• 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.
• Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, 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.
• Maintains awareness of federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
• Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
• Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.
• Performs other related work as needed.

Qualifications

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include 7+ years of work experience in a related job discipline.
• Experience supervising and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, creating monitoring plans) is preferred.
• Experience managing research projects is preferred.
• Experience in a leadership role is preferred.
• Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP) is preferred.

Skills

• Develops a program and a team.
• Excellent time-management skills and the ability to work independently.
• Strategic thinking and ability to work with Principal Investigators.
• Operational and financial analysis of study(ies) and/or program performance.
• Reads and understands clinical trial protocols.
• Knowledge of regulatory policies and procedures.
• Strong analytical skills.
• Grant and contract administration.
• Familiarity with medical and scientific terminology.
• Demonstrated knowledge of Good Clinical Practices (GCP).
• Identifies funding sources.

Benefits

• Benefits eligible.
• Information about the benefit offerings can be found in the Benefits Guidebook.