Clinical Research Coordinator

This position is exempt from Career Service under the CCH Personnel Rules.

Salary is commensurate with years of experience indicated at time of application submittal. Experience not disclosed or documented at the time of application will not be considered for initial step placement.

The Clinical Research Coordinator assists with the study recruitment process, including screening and obtaining consents from eligible candidates. Supports study conduct throughout the lifecycle of the study. Supports and maintains the integrity and quality of clinical research, by ensuring that research is conducted in accordance with Good Clinical Practice (GCP) Guidelines, federal and sponsor regulations and guidelines, institutional policies and procedures, and study protocol.

• Maintains accurate and timely documentation and actively communications with investigators, colleagues, study participants, sponsors, IRB, and other research related entities as needed.
• Ensures study-related procedures are executed per protocol and performed in accordance with protocol timelines.
• Participates in study recruitment, including identifying and screening research participants for study eligibility
• Implements processes to ensure study-related procedures are executed per protocol and performed in accordance with protocol timelines
• Obtains consent from research participants and ensures participants understand the protocol and what is expected of them while participating
• Identifies adverse events based on gained knowledge and reports them in a timely and accurate manner to the principal investigator and appropriate regulatory authorities (IRB, sponsor, etc.)
• Maintains source documents in accordance with institutional procedures
• Packages and ships study-related specimen and/or samples in accordance with Cook County Health System, International Air Transport Association (IATA) and sponsor guidelines
• Obtains and organizes supplies needed to complete study tasks
• Proactively identifies and participates in training, continuing education, and development activities to broaden knowledge and enhance professional development
• Keeps up to date on relevant State and Federal research guidelines and regulations
• Manages risk to the organization(s) and principal investigators by ensuring up-to-date training and compliance in accordance with complex state and federal regulatory statutes and rules
• Manages variety of work requiring critical attention to detail and prioritization

• Associate degree from an accredited college or university or higher
• Two (2) years in a clinical research or relevant experience
• Proficiency using Microsoft Office (Excel and Word)

Bachelor’s degree from an accredited college or university

• Knowledge of medical terminology
• Knowledge of GCP concepts
• Knowledge in setting up, coordinating, and managing clinical research studies
• Knowledge and understanding of policies, procedures, and regulations governing human subject research
• Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations) prior to interacting with research subjects
• Knowledge of components of clinical research operations, including study implementation, oversight, and coordination
• Knowledge of CRF completion, and documentation standards, including timely and accurate transcription of study data
• Ability to analyze, organize, and prioritize work under pressure while meeting deadlines
• Ability to maintain confidentiality
• Skill in completing assignments accurately and with attention to detail
• Excellent interpersonal, written, and verbal communication…