Clinical Research Coordinator 1

University of Chicago; Chicago (IL); On-site; USD 50,000 - 65,000; Full time

Job summary

The University of Chicago Medicine is seeking a Clinical Research Coordinator 1 (CRC1) to support a clinical trial led by the Principal Investigator under the direction of the research program manager.

You will coordinate startup through closeout, screen and recruit subjects, obtain informed consent, collect data, manage study documentation, and ensure protocol compliance while safeguarding patient privacy and complying with regulatory requirements.

Qualifications

• Education: college or university degree in related field.
• Experience: knowledge and skills developed through clinical research environments.
• Certifications: ---

Responsibilities

• Coordinate the conduct of the study from startup through closeout, including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Manage all aspects of conducting clinical trials including screening, enrollment, subject follow-up, case report forms, and adverse event reports.
• Recruit and interview potential study patients with guidance from PI and manager.
• Protect patients and data confidentiality by ensuring security of research data and compliance with federal regulations and sponsor protocols.

Skills

Communication

Organization

Data management

Attention to detail

Reading complex documents

Education

Bachelor's degree

College degree in related field

Tools

Microsoft Word

Excel

Adobe Acrobat

Job description

Department

BSD MED - Emergency Medicine - Beiser Research Staff

About the Department

In existence for over thirty years, the Section of Emergency Medicine is comprised of 27 full-time and 14 part-time faculty members, as well as an outstanding staff of research, administrative and clinical personnel who are devoted to the mission of excellence in patient care, education and research. The Emergency Medicine faculty cover and maintain the staffing and operation of the adult emergency department (ED) at The University of Chicago Medicine. In December 2017, the Section began treating patients in its new, state-of-the art adult ED.

Job Summary

The Clinical Research Coordinator 1 (CRC1) is a specialized researcher working with the Principal Investigator (PI) and under the direction of the research program manager. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC1 supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC1 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Responsibilities

• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Recruit and interview potential study patients with guidance from PI and manager.
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Maintains accurate and complete records which may include, but is not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Accountable for all tasks in basic clinical studies.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• 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
• Certifications: ---

Preferred Qualifications

• Education: Bachelor's degree.
• Experience: Knowledge of medical terminology/environment.

Preferred Competencies

• 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 read and understand complex documents (e.g., clinical trial protocols).
• Ability to handle competing demands with diplomacy and enthusiasm.

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.

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

$50,000.00 - $65,000.00 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