Senior Clinical Research Coordinator
Full Time
Chicago, IL 60637
Posted Today
Job description
Department
BSD MED - Emergency Medicine - Beiser Research Staff
About the Department
In existence for over thirty years, the Section of Emergency Medicine is comprised of 27 full–time and 14 part-time faculty members, as well as an outstanding staff of research, administrative and clinical personnel who are devoted to the mission of excellence in patient care, education and research. The Emergency Medicine faculty cover and maintain the staffing and operation of the adult emergency department (ED) at The University of Chicago Medicine. In December 2017, the Section began treating patients in its new, state-of-the art adult ED.
Job Summary
The Clinical Research Coordinator 2 (CRC 2) provides high level support to the faculty of the Section of Emergency Medicine within the Biological Sciences Division. The CRC 2 will be involved in multiple research trials types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section.
Responsibilities
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Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
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Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
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Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
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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.
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Coordinates 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.
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Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
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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.
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Performs assessments at visits and monitors for adverse events.
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Organizes and attends site visits from sponsors and other relevant study meetings.
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Protects patients' and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
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Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
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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.
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Understands 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.
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Ensures compliance with federal regulations and institutional policies.
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May prepare and maintain protocol submissions and revisions.
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May assist in the training of new or backup coordinators.
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Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
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Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
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Performs other related work as needed.
Minimum Qualifications
Education:
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Work Experience:
Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
Work Experience:
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Certifications:
Certifications:
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Preferred Qualifications
Education:
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Bachelors degree.
Experience:
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Clinical research experience or relevant experience.
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Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).
Preferred Competencies
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Aware of safety hazards and take appropriate precautions.
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Communicate in writing.
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Communicate orally.
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Comprehend technical documents.
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Condense complicated issues to simple summaries that can be understood by a variety of constituents.
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Create and deliver presentations.
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Develop and manage interpersonal relationships.
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Exercise absolute discretion regarding confidential matters.
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Follow written and/or verbal instructions.
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Give directions.
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Handle sensitive matters with tact and discretion.
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Handle stressful situations.
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Learn and develop skills.
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Maintain a high level of alertness.
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Pay attention to detail.
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Perform multiple tasks simultaneously.
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Prioritize work and meet deadlines.
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React effectively, quickly, calmly, and rationally during conflicts and emergencies.
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Train or teach others.
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Work effectively and collegially with little supervision or as member of a team.
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Work independently.
Application Documents
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Resume/CV (required)
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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
Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the
University of Chicago Vaccination GoForward
.
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
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.
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