Clinical Research Manager

* 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.
*
* Education:

*** Master's degree in related field.
*
* Experience:

*** 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.
** Preferred Competencies
*** 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.
** Application Documents
*** Resume/CV (required)
* Cover Letter (preferred)
When applying, the document(s)
** MUST
* * be uploaded via the
** My Experience
** page, in the section titled
** Application Documents
** of the application.

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