UChicago

Clinical Research Operations Manager

Hyde Park Campus Full time

Department

BSD MED - Pulmonary - Tasali Administrative Staff


About the Department

The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of
excellence in each of these important activities.


Job Summary

The Clinical Research Operations Manager is a specialized research professional that is responsible for the direction of research operations in the program. The position works closely with the Principal Investigator (PI) and ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities. The Manager oversees and aides in the development of study material, flowsheets and while supervising trainees, nurses, coordinators and research assistants. The position will participate in writing articles, reports and manuscripts and/or present research findings at meetings and conferences. By performing these duties, the Manager works with the PI, department, and institution to provide guidance on the administration of the compliance, personnel and other related aspects of the clinical study.

Responsibilities

  • Responsible to maintain a high level of knowledge of all research protocols and the day-to-day function of the lab.

  • Oversees the operations of ongoing research projects; including all study materials, assists coordinating and performing study duties as needed. 

  • 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.

  • In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area.

  • Manages personnel, planning, compliance and other administrative aspects of research project(s).

  • Maintenance of laboratory supply inventory and subsequent ordering.

  • 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 and validating 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 and trains research trainees, nurses, coordinators and research assistants.

  • Oversees the day-to-day function of the program including team trainings, hours and meetings.

  • Participates in presenting research findings at meetings and conferences.

  • 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

Education:

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


Work Experience:

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


Certifications:

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Preferred Qualifications

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.


Job Family

Research


Role Impact

People Manager


Scheduled Weekly Hours

40


Drug Test Required

Yes


Health Screen Required

Yes


Motor Vehicle Record Inquiry Required

No


Pay Rate Type

Salary


FLSA Status

Exempt


Pay Range

$90,000.00 - $130,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.


Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.


Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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