Clinical Research Coordinator 1

University of Chicago•Hyde Park, IL

10h•Onsite

About The Position

The Clinical Research Coordinator 1 provides support to the faculty of the Section of Cardiology within the Biological Sciences Division. This role assists with planning and implementing clinical study goals, organizing patient enrollment, conducting quality assurance, and compiling/analyzing data. The coordinator is responsible for collecting, processing, shipping, and storing specimens, coordinating study conduct from startup to closeout, recruiting and screening subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. They also plan patient schedules, educate patients about study procedures and risks/benefits, perform assessments, monitor for adverse events, and serve as a resource for patients on trials. Additionally, this role acts as a collaborator within the department to improve clinical research practice, maintains knowledge of protocols and SOPs, and ensures high standards of clinical research practice. They oversee and participate in complex clinical research studies, ensure compliance with regulations, assist with audits and inspections, and provide support to other research staff. Accurate record-keeping, analysis of study documentation, and quality assurance reviews are also key responsibilities. The role is accountable for all tasks in basic clinical studies and performs other related work as needed.

Requirements

College or university degree in related field
< 2 years of work experience in a related job discipline
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 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

Nice To Haves

Bachelor's degree
Knowledge of medical terminology/environment

Responsibilities

Assist with or plan and implement the clinical study's goals and objectives
Organize patient enrollment planning
Conduct quality assurance activities, compile and analyze data
Collect, process, ship & store specimens to appropriate laboratory according to established techniques
Coordinate the conduct of the study from startup through closeout, including recruiting, interviewing and & screening of study subjects, obtaining informed consent, collecting research data, & ensuring protocol adherence
Plan & coordinate patient schedule for study procedures, return visits, and study treatment schedules
Educate patients about study procedures to be performed, visit schedule, what to report between & during visits, and the risks / benefits of the procedures
Perform assessments at patient study visits and monitor for adverse events
Serve as a resource person to patients on trials
Act as a collaborator within the department/unit through improving clinical research practice and serving as a resource
Maintain working knowledge of current protocols, and internal SOPs
Be accountable for high standards of clinical research practice and assist in the development of accountability in others
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations
Assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors
Provide support to other CRCs and research-related staff, as needed
Maintain accurate and complete records which may include (but are not limited to) signed informed consents, source documentation, Case Report Forms, drug dispensing logs, and study related communication
Analyze study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, progress reports, etc.
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
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples
Accountable for all tasks in basic clinical studies
Performs other related work as needed