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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 ---

Certifications:

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Preferred Qualifications

Education:

Bachelor\'s