Clinical Research Operations Manager Jobs in Tennessee

Department

BSD OCR - Clinical Research Incubation

About the Department

The Office of Clinical Research (OCR) was created to further the research missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center.
The office's mission is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection.
To do this, the work of the OCR is supported by five service units: Human Subject Protection (IRB); Research Compliance; Clinical Research Operational Excellence; Clinical Research Incubation; and Clinical Trial Finance.

Job Summary

The job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.
The Office of Clinical Research, through the Research Incubation Unit, provides research conduct, data management, and regulatory services to departments, sections, and units who are building their research portfolio or who need bridge support during a high growth period or during periods of staffing transitions. The OCR Research Incubation unit provides expertise, infrastructure, staff onboarding, staff training, project management, and staff management for research units in the growth and maintenance stages.
The Clinical Research Coordinator 2 (CRC2) is a specialized research professional working with and under the direction of the Principal Investigator (PI), Co-investigator(s), and other study personnel to follow the clinical protocol. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the CRC 2 is delegated to perform study related tasks across the life cycle of the study. The CRC2 plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within the Bridge Support Unit but will work directly with investigators in one or more clinical departments or specialties. The CRC 2 acts as a key communicator, project manager, and clinical research conduct knowledge partner alongside the investigator, sponsor, and institution to support compliance, financial, personnel and other related aspects of the clinical studies.

Responsibilities

• Participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.

• Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• Act as a liaison with clinical staff, university departments, ancillary departments and/or satellite facilities.

• Maintain working knowledge of current protocols, and internal SOPs. Develop standard work to support efficient workflows.

• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

• Follow procedures, maintain records, track progress, and respond to data queries in timely manner.

• Accountable for all tasks in moderately complex clinical studies.

• Assists with various professional, organizational, and operational tasks under moderate supervision.

• 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 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• Knowledge of medicalterminology/environment.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

• Ability to communicate with tact and diplomacy.

• Strong organizational skills.

• Strong communication skills (verbal and written).

• Excellent interpersonal skills.

• Strong data management skills and attention to detail.

• Knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Ability to understand complex documents (e.g., clinical trials).

• Ability to handle competing demands with diplomacy and enthusiasm.

• Ability to absorb large amounts of information quickly.

• Adaptability to changing working situations and work assignments.

Working Conditions

• Onsite - Indirect Patient Contact.

Application Documents

• Resume (required)

• Cover Letter (preferred)

Job Family

Research

Role Impact

Individual Contributor

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

$60,000.00 - $75,000.00

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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at:http://securityreport.uchicago.edu.Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.