Senior Clinical Research Coordinator

The University of Chicago; Chicago (IL); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in clinical research is seeking a Senior Clinical Research Coordinator to lead and manage complex trials. This role is pivotal in ensuring compliance with regulations while supporting Principal Investigators in achieving study goals. You will be at the forefront of innovative research, coordinating activities, and providing guidance across various departments. If you have a passion for clinical research and a knack for problem-solving, this is an exciting opportunity to contribute to groundbreaking studies and make a difference in patient care.

Qualifications

• 5-7 years of clinical research experience required.
• Master's degree preferred for advanced coordination roles.

Responsibilities

• Oversee daily activities of complex clinical trials.
• Ensure compliance with federal and institutional regulations.
• Coordinate with PIs and manage research documentation.

Skills

Clinical Research Coordination

Data Management

Regulatory Compliance

Analytical Skills

Time Management

Education

Bachelor's degree in a related field

Master's degree

Tools

IRB submission systems

Clinical trial management software

Job description

Department

BSD MED - Pulmonary - Clinical Research 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 Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Section Administrator and/or Clinical Research Manager within the Section of Pulmonary/Critical Care Medicine in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr. CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.

Responsibilities

• Leads within the department/unit through improving clinical research practice and serves as a resource to others.
• Works with the PIs, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
• Assists with or plans and implements the clinical study's goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
• Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
• Serves as a resource person or acts as a consultant within area of clinical expertise.
• Maintains working knowledge of current protocols, and internal SOPs.
• Accountable for high standards of clinical research practice and assists in the development of accountability in others.
• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.
• Prepares, submits, and assists Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provides Investigators with guidance regarding protocol requirements.
• Maintains regulatory documentation.
• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Provides direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
• Attends continuing education and training opportunities relevant to job duties.
• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.
• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• Accountable for all tasks in complex clinical studies.
• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
• Performs other related work as needed.

Minimum Qualifications

Education:

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

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Master's degree.

Experience:

• Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP).

Preferred Competencies

• Develop a program and a team.
• Excellent time management skills and ability to work independently.
• Develop research program and work strategically with Principal Investigator(s).
• Lead robust operational and financial analysis of study(ies) and/or program performance.
• Read and 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).
• Identify funding sources.

Application Documents

• Resume/CV (required)
• Cover Letter (required)

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

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

37.5

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

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