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Clinical Research Coordinator 2

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Sunday, January 14, 2024

Department

BSD MED - Endocrinology - Kovler Research Staff


About the Department

The Clinical Research Coordinator 2 will work as part of the Kovler Diabetes Center in the Department of Medicine, Section of Adult and Pediatric Endocrinology, Diabetes, and Metabolism at the University of Chicago. The Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism is consistently recognized as one of the finest endocrinology centers in the U.S. The University of Chicago’s endocrinology program has a reputation for progressive therapies and leading-edge research. The Kovler Diabetes Center is a globally renowned research hub and a treatment center of choice. The Center is…
• Focused. Diabetes is all we do.
• Patient centered. We empower our patients through treatment, education and specialist access. The patient is our highest priority.
• Comprehensive. Kovler encompasses research, patient care, professional training, and patient education.
• Science based. Evidence is the foundation of our treatment protocol. We focus on applied research to enhance patient care.
• Multidisciplinary. Our team of specialists and educators addresses the full range of patient needs, from the physical to the social and emotional.
To learn more, please visit: https://www.uchicagomedicine.org/conditions-services/diabetes


Job Summary

The Clinical Research Coordinator 2 provides support to the faculty of the Kovler Diabetes Center within the Biological Sciences Division. The CRC 2 will be involved in multiple research trial types, such as: 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 Center. This CRC 2 will work primarily with the University of Chicago Monogenic Diabetes Registry and related studies: https://monogenicdiabetes.uchicago.edu.

Responsibilities

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

  • Recruit and interview potential study patients with guidance from PI and other clinical research staff.

  • Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

  • Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

  • Coordinate 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.

  • Understand 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.

  • Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

  • 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 in diabetes.

Preferred Competencies

  • Aware of safety hazards and take appropriate precautions.

  • Communicate in writing.

  • Communicate orally.

  • Comprehend technical documents.

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

  • Create and deliver presentations.

  • Develop and manage interpersonal relationships.

  • Exercise absolute discretion regarding confidential matters.

  • Follow written and/or verbal instructions.

  • Give directions.

  • Handle sensitive matters with tact and discretion.

  • Handle stressful situations.

  • Learn and develop skills.

  • Maintain a high level of alertness.

  • Pay attention to detail.

  • Perform multiple tasks simultaneously.

  • Prioritize work and meet deadlines.

  • React effectively, quickly, calmly, and rationally during conflicts and emergencies.

  • Train or teach others.

  • Work effectively and collegially with little supervision or as member of a team.

  • Work independently.

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.

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