Clinical Research Manager
Hyde Park Campus
About the Unit
The Department of Anesthesia & Critical Care is a clinical academic department at the University of Chicago.
The Clinical Research Manager is a specialized research professional who will be responsible for the direction of the clinical research programs within the Department of Anesthesia & Critical Care. The Manager works closely with the clinical Principal Investigators (PIs) on long-range plans for research studies. While the PIs are primarily responsible for the overall design and conduct of the clinical trials, the Manager collaborates with the PIs and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. The Manager ensures clinical research projects progress according to plan by overseeing the coordination of the daily clinical trial activities. The Manager may be asked to negotiate trial budgets, write articles, reports and manuscripts and/or present research findings at meetings/conferences. By performing these duties, the Manager works with the PIs, section, department, sponsor, and institution to provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
Research Conduct/Study Management:
- Supervises both researchers and research support staff.
- Conducts research in 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 applications of technology.
- Establishes goals and operating procedures, practices, and guidelines.
- Establishes, monitors, and controls project budgets.
- 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.
- Coordinate 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.
- Protect 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.
- Understand 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.
- Understand the federal research regulations and identify the federal research organizations' role in regulating human research participation.
- Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
- Ability to develop a program and a team required.
- Excellent time management skills and ability to work independently required.
- Ability to develop research program and work strategically with Principal Investigator(s) required.
- Ability to lead robust operational and financial analysis of study(ies) and/or program performance required.
- Ability to read and understand clinical trials protocols required
- Knowledge of regulatory policies and procedures required.
- Strong analytical skills required.
- Knowledge of grant and contract administration required.
- Familiarity with medical and scientific terminology required.
- Demonstrated knowledge of Good Clinical Practices (GCP) required.
- Ability to identify funding sources preferred.
- Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP) preferred.
- Knowledge of human resource functions preferred.
Education and Experience:
- Bachelor's degree required.
- Master's degree preferred.
- Minimum of 5 years of clinical research experience or research experience combined with relevant experience required.
- Minimum of 1 year of management (personnel, program and/or project management) required.
- Supervisory skills preferred.
- Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans) preferred.
- Experience managing research projects preferred.
- Experience in a leadership role preferred.
- Resume Required
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Remove from Posting On or Before
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