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BSD DFI - Clinical Studies

About the Department

The Duchossois Family Institute (DFI) at the University of Chicago Medicine promotes wellness through groundbreaking science on the immune system, genetics, the microbiome, and their shared environments. Introducing a new science of wellness, the DFI aims to maximize good health and the economic, social, and personal benefits it delivers. The DFI comprises a multidisciplinary team of scientists, physicians, data analysts, and entrepreneurship specialists who work together to accelerate development of this innovative, paradigm-shifting approach to health.

Job Summary

The DFI performs microbiome analyses on patients undergoing heart and/or liver transplantation, cancer treatment and intensive care hospitalization under protocols that have been approved the University of Chicago IRB. The clinical research coordinator will report to the DFI clinical research studies manager and assist in all aspects of the clinical research studies to ensure compliance with protocol and applicable institutional and regulatory guidelines.

It is anticipated that the findings of these studies will lead to the optimization of patient recovery from complex medical therapies, with reduced complication rates, including antibiotic-resistant infections, and shortened hospital stays.

Responsibilities

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report forms, adverse event reporting, and ensuring protocol adherence.
• In-person patient consenting.
• Transporting patient specimens from the clinic or hospital unit to the research laboratory.
• Coordinating with couriers involved in at-home to-hospital sample collection.
• Performs data entry and statistical analysis (data collection, summary stats, sample collection metrics, etc.).
• Assisting with the development of source documentation, subject and specimen trackers, and REDCap forms.
• Phoning patients for surveys and appointment reminders.
• Assisting with enrollment, data collection, specimen tracking, adverse event monitoring and other assigned tasks in a Phase 1 clinical trial.
• Acts as a liaison with medical staff, university departments, ancillary departments.
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF\'s), drug dispensing logs, and study related communication.
• 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.
• Ensures compliance with federal regulations and institutional policies.
• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• 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

Experience:

• Two years of previous work i clinical research is strongly preferred.
• Experience coordinating multiple studies is strongly preferred.
• Experience working with computers, databases and Excel. REDCap experience is a plus.

Preferred Competencies

Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

A genuine interest in working in health disparities research.

Strong organizational skills.

Strong communication skills (verbal and written).

Excellent interpersonal skills.

Strong data management skills and attention to detail.

Competences in using Microsoft Word, Excel, PowerPoint, Adobe Acrobat.

Ability to perform basic statistical analysis.

Ability to read and understand complex documents (e.g., clinical trial protocols).

Ability to handle competing demands with diplomacy and enthusiasm.

Ability to work independently as well as in a team environment.

Adaptability to changing worki