Clinical Research Coordinator II

Department

BSD OBG - Research Staff

About the Department

The Department of Obstetrics and Gynecology has 136 clinical providers providing care at the main hospital in Hyde Park and multiple offsite locations. We have more than 68,000 outpatient visits, 28,000 ultrasound visits, 2,800 deliveries, and 3,300 surgeries per year. Teaching, research, and the highest quality clinical care are top priorities for the Department. The residency and fellowship programs are highly ranked and have a history of training leaders in healthcare. The Department also has a significant research enterprise, engaging in population health studies, as well as research conducted in wet laboratories on tumor biology, fibroid research, and hypertensive diseases in pregnancy.

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 Clinical Research Coordinator II independently manages and executes moderately complex clinical research studies from start up through close out. This role serves as a central operational lead, ensuring scientific integrity, regulatory compliance, and seamless coordination across investigators, sponsors, and multidisciplinary teams. The Coordinator plans and conducts clinical and non clinical research activities, oversees participant recruitment and study visits, manages data collection and reporting, and supports dissemination of findings through publications and presentations.

This position exercises professional judgment in navigating regulatory requirements, financial considerations, and study logistics, while maintaining strict adherence to institutional, state, and federal guidelines. The role contributes directly to advancing research initiatives across the University by ensuring studies are executed efficiently, ethically, and in alignment with sponsor expectations.

Responsibilities

• Develop study protocols, CRFs, and other study documents.

• Working closely with Principal Investigators (PIs) and laboratory team members.

• Technical proficiency and ability to operate, troubleshoot, and maintain specialized laboratory machinery. 

• Sample preparation, including collecting, labeling, and processing biological samples for testing. 

• Setting up experiments, running protocols (e.g., cell culturing, DNA extraction, PCR, ELISA, and staining slides and microscopy), and assisting with animal care and study design.

• Data management, collecting, recording, and analyzing data, often using computerized equipment.

• Keep detailed documentation of lab notebooks that document every step of an experiment. Lab maintenance, cleaning equipment, managing inventory, and handling hazardous materials.

• Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.

• Collect, archive subjects’ data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstracts at national and international conferences.

• Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.

• Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.

• This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.

• Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.

• Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.

• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, perform and supervise various study visit procedures, and participate in program audits.

• Prepares program conference lists for multidisciplinary conferences and workshops.

• Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

• Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.

• Accountable for all tasks in moderately complex clinical studies.

• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.

• 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:

• College or university degree in related field.

• Advanced degree in research or a related field strongly preferred.

Experience:

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

• Previous clinical trials experience.

• Previous IRB protocol experience.

Preferred Competencies

• Ability to independently coordinate and manage moderately complex clinical research studies from start up through close out.

• Knowledge of IRB processes, regulatory requirements, and institutional, state, and federal research policies.

• Strong data management and analytical skills, including experience with REDCap, Excel, and other research data systems.

• Understanding of research methodologies and basic laboratory techniques applicable to clinical and non clinical studies.

• Sound problem solving skills with the ability to exercise professional judgment in resolving study related operational, compliance, and financial issues.

• Effective collaboration and communication skills when working with investigators, sponsors, multidisciplinary teams, and external partners.

• Strong organizational skills and attention to detail with the ability to manage multiple studies and competing priorities.

Working Conditions

• Work is performed primarily in an outpatient clinical setting with additional responsibilities in a laboratory environment.

• Requires travel between multiple clinical sites as needed to support study activities.

• Requires prolonged periods of standing during clinical or study related activities.

• Requires extended periods of computer use for data entry, documentation, and reporting.

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

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FLSA Status

Exempt

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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.

 

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