Clinical Research Manager

University of Chicago • Chicago, IL

21h • $90,000 - $130,000

About The Position

The Department of Neurology at The University of Chicago Medical Center has a great history and tradition, having made significant contributions to neurological training, clinical care, and the basic understanding of neurological disease. 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.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Nice To Haves

• Master's degree in related field.
• Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
• Experience managing research teams and projects.
• Experience in a leadership role.
• Ability to develop and manage clinical trials teams.
• Excellent time management skills and ability to work independently.
• Ability to develop and develop research programs and work strategically with Principal Investigators.
• Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
• Ability to understand clinical trials protocols.
• Knowledge of regulatory policies and procedures.
• Strong analytical skills.
• Knowledge of grant and contract administration.
• Familiarity with medical and scientific terminology.
• Demonstrated knowledge of Good Clinical Practices (GCP).
• Ability to identify funding sources.

Responsibilities

• Provide project management, data management and clinical monitoring support for multiple types of trials (sponsored, grant funded, multi-site, and/or investigator-initiated trials) in the Department of Neurology.
• Act as a liaison between clinical sites, the Clinical Trials Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol and applicable institutional and regulatory guidelines.
• Responsible for research project oversight and day-to-day supervision of Clinical Research Coordinators and other research staff employees as appropriate.
• Establishes, monitors, and controls project budgets, ensuring financial performance is robust.
• Conducts research in area of expertise.
• Collaborates with PI’s and other researchers on long-range plans for research projects.
• Oversees the development of research projects and ensures progress according to plan.
• Investigates, modifies and applies new procedures, techniques or applications of technology.
• Establishes goals and operating procedures, practices, and guidelines.
• In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in 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.
• 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 patients and data confidentiality by ensuring 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 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.
• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research 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.
• Performs other related work as needed.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
• Information about the benefit offerings can be found in the Benefits Guidebook.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees