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Clinical Research Coordinator 1

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Monday, February 12, 2024

Department

BSD MED - Center for Health and the Social Sciences - Oral Health


About the Department

Center for Health and the Social Sciences (CHeSS) has designed a new research project ‘A Randomized Control Trial on the Effects of No-Fee Basic Dental Care on Systemic Health of Older Adults’. The clinical trial launched in the Summer 2019. By doing this study, we hope to learn about how offering no-fee dental care to older adults for a period of 5 years who do not have coverage for dental care and are not receiving regular dental cleanings affects their quality of life, health and health care costs.


Job Summary

The Clinical Research Coordinator 1 (CRC1) is a specialized researcher working with the clinical Principal Investigator (PI) and under the direction of a departmental research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC1 supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC1 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study. Provide technical and administrative support for the Program in Oral Health, Systemic Health, Well-Being and the Social Sciences Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

Responsibilities

  • Recruits, interviews and collects intraoral images of potential study patients with guidance from PI and other clinical research staff.

  • 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.

  • Manages day-to-day functioning of the study dental clinic including managing equipment sterilization, inventory of supplies and instruments and other clinic related activities.

  • Manages day-to-day activities of the clinical study and research assistants.

  • Protects 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.

  • Manages identification, collection, labeling, filing of all images and integrating with other respondent information.

  • 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), dental clinic documentation, 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.

  • Understands the federal research regulations and identifies the federal research organizations’ role in regulating human research participation.

  • May prepare and maintain protocol submissions and revisions.

  • 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).

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Bachelor's degree.


Experience:

  • Knowledge of medical terminology/environment.

Technical Skills or Knowledge:

  • Knowledge of Microsoft Word, Excel and Adobe Acrobat.

Preferred Competencies

  • Interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

  • Communicate with tact and diplomacy.

  • Strong organizational skills.

  • Strong communication skills, verbal and written.

  • Excellent interpersonal skills.

  • Strong data management skills and attention to detail.

  • Ability to understand complex documents (e.g., clinical trials).

  • Handle competing demands with diplomacy and enthusiasm.

  • Absorb large amounts of information quickly.

  • Adaptability to changing working situations and work assignments.

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

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.

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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