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Clinical Research Coordinator 2

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Saturday, November 18, 2023

Department

BSD MED - Gastroenterology - Clinical Research Staff


About the Department

The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialty nationally by U.S News and World Report. With nearly 30 specialists on staff, our program plays a leading role in the understanding of digestive diseases and in developing innovative and successful treatments for patients. Since forming the nation’s first full-time department of gastroenterology in 1927, our physicians have continually improved treatments for digestive tract and related disorders by combining medical research, education, and patient care at the highest level.


Job Summary

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager in the Section of Gastroenterology in the Department of Medicine.

Responsibilities

  • Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

  • Recruits and interviews potential study patients with guidance from PI and other clinical research staff.

  • Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.

  • 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.

  • 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.

  • Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

  • 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.

  • Performs assessments at visits and monitors for adverse events.

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

  • Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

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

  • 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.

  • 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.

  • Ensures compliance with federal regulations and institutional policies.

  • May prepare and maintain protocol submissions and revisions.

  • May assist in the training of new or backup coordinators.

  • Responsibilities may include the following non-laboratory duties: May assist in recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support.

  • Responsibilities may include the following laboratory duties: setting up and performing experiments; interacting with students and other laboratory staff under the direction of the principal investigator.

  • Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

  • Analyzes 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 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:

  • Bachelors degree.

Experience:

  • Clinical research experience or relevant experience.

  • Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies

  • Ability to be aware of safety hazards and take appropriate precautions.

  • Ability to communicate in writing.

  • Ability to communicate orally.

  • Ability to comprehend technical documents.

  • Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.

  • Ability to create and deliver presentations.

  • Ability to develop and manage interpersonal relationships.

  • Ability to exercise absolute discretion regarding confidential matters.

  • Ability to follow written and/or verbal instructions.

  • Ability to give directions.

  • Ability to handle sensitive matters with tact and discretion.

  • Ability to handle stressful situations.

  • Ability to learn and develop skills.

  • Ability to maintain a high level of alertness.

  • Ability to pay attention to detail.

  • Ability to perform multiple tasks simultaneously.

  • Ability to prioritize work and meet deadlines.

  • Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.

  • Ability to train or teach others.

  • Ability to work effectively and collegially with little supervision or as member of a team.

  • Ability to work independently.

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

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.

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