Clinical Research Manager
Hyde Park Campus
About the Unit
During the past three decades, the Kovlers have been important supporters and partners in advancing the breakthrough work of the UChicago Medicine's (UCM) internationally recognized scholars in diabetes, cancer and infectious diseases and in improving the quality of life for countless individuals. Jonathan's positive experience as a UCM patient and the family's longstanding relationship with the University inspired the Kovlers to support the its growth in diabetes research and care. The Kovler family helped establish the Kovler Laboratories in 1978, creating an environment for research to thrive and leading to many breakthrough discoveries. Their investments have supported renowned physicians and scientists such as David Ehrmann, M.D., Donald Steiner, M.D. and Graeme Bell, Ph.D., all of whom have advanced diabetes research in meaningful ways. The Kovlers shared the bold vision of the University's leaders to create a center for diabetes research and care, understanding that its creation would deliver exponential returns for patients and their families. A named center would serve as a destination for diabetes patients and their families to access the latest in treatment options and clinical trials, and also receive vital support and education for diabetes management. The center would also support cutting-edge scientific research and lead the way in educating future diabetes specialists. This vision became a reality in 2006 when the Kovler Diabetes Center brought together the University's exceptional talent in diabetes research, care and education. Today, the UChicago Medicine Kovler Diabetes Center continues to be at the forefront of providing patient-centered, comprehensive care while pursuing basic and clinical research, as well as translating discoveries to the bedside, and educating medical specialists, patients and the broader community about diabetes.
The Clinical Research Manager (Manager) is a specialized research professional that is responsible for the direction of a program or a research office. The Manager works closely with the clinical Principal Investigator (PI) on long-range plans for research studies. While the PI is primarily responsible for the overall design and conduct of the clinical trials, the Manager collaborates with the PI 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 research projects progress according to plan by overseeing the coordination of the daily clinical trial activities. The Manager will write articles, reports and manuscripts and/or present research findings at meetings/conferences. By performing these duties, the Manager works with the PI, 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:
- Responsible for the direction of a program or research office.
- 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.
- Supervises both researchers and research support staff.
- Writes articles, reports and manuscripts.
- Presents research findings at meetings and/or conference.
- 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:
- 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.
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Background Check Required?
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