Department

BSD SUR - Research Services: Investigator Initiated Trials

About the Department

Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery's mission is to meet the most challenging and complex health problems on both a local and global scale.

Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery. In addition to our department's clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.

This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff. We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.

Job Summary

The job independently manages the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data. Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the Department of Surgery.

Responsibilities

Oversees and manages the workload of junior clinical research coordinators.   

Leads start-up activities for investigator initiated trials and provides necessary back-up.

Conducts office management and supply ordering for IIT team.

Independently coordinates upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.

Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

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

Conducts site initiation visits with subsites/collaborators.

Performs assessments at visits and monitors for adverse events.

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

Protects patients and data confidentiality by ensuring security of research data and personal health information.

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

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.

Manages a portfolio of projects that may include rigorous social science evaluations and technical assistance data analysis projects.

Accountable for all tasks in complex clinical studies.

Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.

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 Competencies

Ability to train others and provide constructive feedback.

Excellent oral and written communication skills.

Strong project management skills, strategic problem solving and attention to detail.

Ability to understand complex protocols to assist with billing and budget discussions.

Strong interpersonal skills.

Commitment to providing a high level of service.

Ability to work independently and as part of a team.

Ability to handle sensitive and confidential situations and information with absolute discretion.

Ability to work well under pressure.

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.

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

​
FLSA Status

Exempt

​
Pay Range

$70,000.00 - $85,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

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

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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: http://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.