Biological Sciences Division at the University of Chicago · 5 hours ago
Clinical Research Manager
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$90K/yr - $130K/yr
7+ years expThe Biological Sciences Division at the University of Chicago is known for its significant contributions to neurological training and clinical care. They are seeking a Clinical Research Manager to oversee clinical research activities, manage staff, and ensure compliance with regulatory guidelines.
Higher Education
Responsibilities
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 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
Qualification
Required
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
Resume/CV (required)
Preferred
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
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
Company
Biological Sciences Division at the University of Chicago
As part of the University of Chicago, the Biological Sciences Division (BSD) pursues globally impactful solutions to seemingly unsolvable challenges.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase