Clinical Research Manager

Overview

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 Clinical Research Manager will 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.
• The Clinical Research Manager will 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 PIs 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.

Minimum Qualifications
Minimum requirements include a college or university degree in related field.

Minimum Experience
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Preferred Qualifications

• 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.
• Know…