Clinical Research Coordinator 2 - JR22163-3800

at University of Chicago in Chicago, Illinois, United States

Job Description

• 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.
  
• Provide day-to-day support to dental team including dental hygienists and dentists who are a part of the Oral Health study clinic.
  
• 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.
  
• Managing 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.
  
• 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.
  

• Bachelor's degree.
  

• Knowledge of medical terminology/environment.
  

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
  
• Ability to 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.
  
• Knowledge of Microsoft Word, Excel and Adobe Acrobat.
  
• Ability to read and understand complex documents (e.g., clinical trials).
  
• Ability to handle competing demands with diplomacy and enthusiasm.
  
• Ability to absorb large amounts of information quickly.
  
• Adaptability to changing working situations and work assignments.
  

• Resume (required)
  
• Cover Letter (required)