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

About the Department

The 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. Provides 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 proc ss 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.
• 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 ---

Certifications:

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Preferred Qualifications

Education:

• Bachelor\'s degree.

Technical Skills or Knowledge:

• Medical terminology/environment.
• Microsoft Word, Excel and Adobe Acrobat.

Preferred