Clinical Research Coordinator II

Department

BSD MED - Cardiology - Clinical Research Staff

About the Department

The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees, and support staff and is enhanced by the rich environment at the University of Chicago. The Section of Cardiology, within the Department of Medicine, is a highly collaborative workplace on the main campus of the University of Chicago.

Job Summary

The Clinical Research Coordinator II (CRCII) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRCII supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRCII 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

• Manages all aspects of conducting clinical trials including screening, consenting, enrollment, subject follow-up, completion of case report forms, adverse event reports, data entry, specimen collection, processing, and shipment.

• Coordinates the conduct of the study from start-up through close-out, including recruitment, obtaining informed consent, screening study subjects, collecting research data, ensuring protocol adherence, and data integrity.

• In partnership with the PI, expand amyloid clinical research to affiliated University of Chicago’s satellite sites and increase program reach through community education and outreach regarding amyloidosis.

• Plans and coordinates patient schedules for study procedures, return visits, and study treatment schedules. Performs assessments at visits and monitors for adverse events.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, drug dispensing logs, and study related communication.

• Ensures compliance with federal regulations and institutional policies.

• 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.

• Accountable for all tasks in moderately complex clinical studies.

• 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:

• Bachelors degree.

Experience:

• 4 years clinical research experience, minimum 2 years with amyloidosis, oncology, heart failure or experience in related disease process.

• Leadership and clinical project management.

Technical Skills or Knowledge:

• Human specimen processing and shipping.

• Working knowledge coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies

• Excellent communication skills, orally and written.

• Create and deliver presentations.

• Develop and manage interpersonal relationships.

• Ability to multi-task successfully.

• Prioritize work appropriately and meet deadlines.

• Work autonomously, effectively, and collegially.

• Facilitate collaboration between university and hospital leadership.

• Familiarity with EPIC – electronic medical record.

Working Conditions

• This is an on-site position.

• This role is patient-facing.

Application Documents

• Resume/CV (required)

• Cover Letter (required)