Senior Clinical Research Coordinator, Amyloid Research

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 Senior Clinical Research Coordinator, Amyloid Research (Sr. CRC, Amyloid Research) is an on-site, patient-facing, specialized researcher partnering with the Principal Investigator (PI) and under the direction of the section’s clinical research manager. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the position plays a critical role in the conduct of various studies. S/he supports, facilitates, and independently coordinates the daily clinical trial activities. The role works with the PI, department, sponsor, and institution to support and provide guidance on the administration, compliance, financial and other related aspects of various clinical studies. The position will support and expand the University of Chicago’s Amyloidosis Program through the volume of clinical trials opened, participants recruited, and number of sites amyloid trials are offered.

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.

• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.

• Ensures compliance with federal regulations and institutional policies.

• Accountable for all tasks in complex clinical studies.

• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.

• 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 5-7 years of work experience in a related job discipline.

Certifications:

---

Preferred Qualifications

Experience:

• Leadership and clinical project management.

• 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.

• Maintain a high level of alertness.

• 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 EP