Clinical Research Coordinator II

University of Chicago • Chicago, IL

1d • $60,000 - $75,000

About The Position

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.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Nice To Haves

• College or university degree in related field.
• Advanced degree in research or a related field strongly preferred.
• 2-5 years of work experience in a related job discipline.
• Previous clinical trials experience.
• Previous IRB protocol experience.
• 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.

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.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level