Clinical Research Coordinator 1, Cardiac Surgery

Department
BSD SUR - Research Services
About the Department
The Section of Cardiac Surgery at the University of Chicago draws upon a tradition of innovative clinical practice and scientific research to provide the highest level of care to our patients. We continue to pioneer and develop new programs and techniques.
Our cardiac surgeons have established a renowned heart transplant program, which is the largest in Illinois and second largest in the Midwest. Our program's physicians and surgeons were the first to successfully simultaneously perform a heart, liver and kidney transplant and have extensive experience in multiple organ transplants. Complementing these complex surgical techniques is our faculty's vast experience in minimally invasive surgical techniques. We were the first to perform a DaVinci-assisted coronary artery bypass graft surgery in Chicago and routinely perform minimally invasive valve surgeries, including complex redo valves.
Our pediatric cardiac surgeons are also at the forefront of surgical procedures. Our state-of-the-art Comer Children's Hospital allows our faculty to enhance and expand their innovative and pioneering work in hybrid surgery: a minimally invasive, off-pump approach for newborns suffering from hypoplastic left heart syndrome. This technique buys time, enables the infant to survive without a massive operation soon after birth and allows the child to grow for several months, which makes follow-up operations easier.
Our team of scientists are committed to improving our understanding of complex heart diseases and uncovering new ways of tackling these conditions. This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment toward the shared goal of improving the health of patients in our community and beyond.
Job Summary
The job provides technical support activities related to documents and reports on Clinical Research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact Clinical Research conducted across the University. Plans and coordinates patient schedules for study procedures, return visits, and study schedules.
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.
• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Performs other related work as needed.

Minimum Qualifications
Education:
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Certifications:
Preferred Qualifications
Education:

• Bachelor's Degree in a related field.

Preferred Competencies

• Ability to 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.
• Ability to read and understand complex documents.
• Ability to handle competing demands.
• 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.

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
FLSA Status
Non-Exempt
Pay Frequency
Biweekly
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.
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