Department
 

BSD SUR - Research Services: Investigator Initiated Trials

About the Department
 

At UChicago Medicine, faculty and staff in the Section of Plastic and Reconstructive Surgery are dedicated to caring for patients suffering: covering the entire spectrum of plastic, reconstructive, and aesthetic surgery from breast reconstruction to craniomaxillofacial and microsurgery.

Many faculty members are credited with pioneering several highly technical approaches in post-oncologic reconstructive surgery for cancer survivors, hand surgery, craniofacial surgery, and much more. Our plastic surgeons are also prepared to care for patients seeking cosmetic aesthetic surgery. They are committed to working with each patient to achieve the patient's desired outcome.

In addition, investigators in plastic and reconstructive surgery conduct rigorous research, particularly in the area of tissue engineering and craniofacial/bone biology. Their work would have widespread implications for individuals with craniofacial defects, such as those caused by trauma or tumor surgery.

Job Summary
 

This position performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the Department of Surgery.

Responsibilities

Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques.Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.Organizes and actively participates in site visits from sponsors and other relevant study meetings.Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.Performs other related work as needed. 

Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

Bachelor's degree in a related field.

Technical Skills or Knowledge:

Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.Knowledge of medical terminology.Understanding of the IRB submission and review process and when and how to apply for IRB review.Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation.

Preferred Competencies

Interact and communicate with clarity, tact, and courtesy with patients, staff, faculty, students, and others.Strong organizational skills.Strong communication skills, verbal and written.Strong data management skills and attention to detail.Read and understand complex documents.Handle competing demands.

Application Documents

Resume/CV (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

FLSA Status
 

Exempt

Pay Frequency
 

Monthly

Scheduled Weekly Hours
 

40

Benefits Eligible
 

Yes

Drug Test Required
 

Yes

Health Screen Required
 

Yes

Motor Vehicle Record Inquiry Required
 

No

Posting Statement
 

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

 

Staff 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.

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

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.