Clinical Research Coordinator 1

Department

BSD MED - Pulmonary - Clinical Research Staff

About the Department

The University of Chicago’s Respiratory Clinical Research team assists Principal Investigators in conducting drug trials, device trials, observational studies, databases, and biorepositories for a range of pulmonary diseases. The clinical research core provides support to nine Principal Investigators, who conduct both industry sponsored and grant funded projects (federal and foundation).

Job Summary

The Clinical Research Coordinator 1 (CRC 1) provides support to the faculty of the Section of Pulmonary/Critical Care within the Department of Medicine. The CRC 1 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Coordinate all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• Maintain accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Plan and coordinate patient schedule for study procedures, return visits, and study treatment schedules.

• Ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Prepare and maintains protocol submissions and revisions.

• Educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.

• Perform assessments at visits and monitors for adverse events.

• Organize and attend site visits from sponsors and other relevant study meetings.

• May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.

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

Certifications:

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Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• Experience with clinical coordinating.

• Experience with REDCap.

• Experience with primary data entry and analysis.

• Experience working with human research subjects.
   

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.

Application Documents

• Resume (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.

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