Job Description

Job Description:

• 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 other clinical research staff.  

• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

• 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.

• 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 are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Understand 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.  

• May prepare and maintain protocol submissions and revisions.

• May assist in the training of new or backup coordinators.

• Assists with and performs various administrative and operational tasks under moderate to limited supervision.

• 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.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contribute to the problem-solving on assigned clinical research studies and tasks.

• 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 charts, and participation in program audits.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

• Performs other related work as needed.

Preferred Qualifications

Education:

• Bachelorâ™s Degree.

Experience:

• Direct patient contact experience.

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

• Experience using electronic medical records systems (EMR).

Technical Skills and Knowledge:

• Strong data management skills.

• Knowledge of Microsoft Office and Adobe Acrobat.

Preferred Competencies

• Absorb large amounts of information quickly.

• Adaptability to changing working situations and work assignments.

• Attention to detail.

• Interact and communicate (verbal and written) with clarity, tact, and courtesy with patrons, patients, staff, faculty, students and others.

• Read and understand technical documents.

• Time management and task prioritization.

• Modeling ethical and compliant conduct of clinical research.

• Recognize and analyze issues requiring resolution.

• Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation. 

• Exercise absolute discretion regarding confidential matters.

• Follow written and/or verbal instructions and give direction to others.

• Handle sensitive matters with tact and discretion, including stressful situations.

• Ability to maintain a high level of alertness and perform multiple tasks simultaneously.

• React effectively, quickly, calmly, and rationally during conflicts and emergencies.

• Ability to train or teach others.

Working Conditions

• Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration.

Application Documents

• Resume (required)

• Cover Letter (required)

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

About University of Chicago (UC)

One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.

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