Clinical Research Coordinator 1

University of Chicago•Hyde Park, IL

22h•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 specimen collection, processing, shipping, and storage, as well as coordinating study conduct from startup to closeout. This includes recruiting, interviewing, and screening subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. The role also involves planning patient schedules for procedures and visits, educating patients about study protocols, performing patient assessments, monitoring for adverse events, and serving as a resource for patients on trials. Additionally, the coordinator acts as a collaborator within the department to improve clinical research practices, maintains knowledge of current protocols and SOPs, and ensures high standards of clinical research practice. They will 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 participation in 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

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Nice To Haves

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 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.

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.