ICH E6(R3) Section 4.2
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The clinical research coordinator serves as the operational backbone of clinical trial conduct at the site level, managing the complex logistics and detailed requirements that determine whether a trial succeeds or fails. Working under the investigator's supervision, the CRC coordinates participant recruitment and scheduling, administers study procedures, collects and enters data, maintains regulatory documentation, and serves as the primary point of contact for sponsors and monitors. This multifaceted role requires exceptional organizational skills, attention to detail, and the ability to work effectively with diverse stakeholders.
CRC responsibilities span the entire participant journey through a clinical trial. Before enrollment, coordinators screen potential participants against protocol eligibility criteria, coordinate the informed consent process, and schedule baseline assessments. During participant follow-up, they ensure that study visits occur within protocol-specified windows, that all required assessments are completed, that adverse events are identified and reported, and that participants remain engaged and informed about the study. At study conclusion, coordinators manage closeout activities and ensure that documentation is complete and properly archived.
The relationship between the CRC and the investigator is collaborative and complementary. While the investigator retains responsibility for medical decisions and participant safety, the CRC handles the operational implementation that makes those decisions effective. Strong CRCs anticipate problems before they occur, maintain meticulous documentation, and serve as advocates for both participant welfare and data quality. The position has become increasingly professionalized, with certification programs and professional organizations supporting career development.
Participant management
"The clinical research coordinator called the participant the day before each scheduled visit to confirm the appointment, remind them of fasting requirements, and answer any questions about what to expect."
Data management
"After each study visit, the CRC entered data into the electronic case report form, resolved any automatic edit checks, and filed source documents in the participant's study binder."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.
ICH E6(R3) Section 4.2
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The clinical research coordinator serves as the operational backbone of clinical trial conduct at the site level, managing the complex logistics and detailed requirements that determine whether a trial succeeds or fails. Working under the investigator's supervision, the CRC coordinates participant recruitment and scheduling, administers study procedures, collects and enters data, maintains regulatory documentation, and serves as the primary point of contact for sponsors and monitors. This multifaceted role requires exceptional organizational skills, attention to detail, and the ability to work effectively with diverse stakeholders.
CRC responsibilities span the entire participant journey through a clinical trial. Before enrollment, coordinators screen potential participants against protocol eligibility criteria, coordinate the informed consent process, and schedule baseline assessments. During participant follow-up, they ensure that study visits occur within protocol-specified windows, that all required assessments are completed, that adverse events are identified and reported, and that participants remain engaged and informed about the study. At study conclusion, coordinators manage closeout activities and ensure that documentation is complete and properly archived.
The relationship between the CRC and the investigator is collaborative and complementary. While the investigator retains responsibility for medical decisions and participant safety, the CRC handles the operational implementation that makes those decisions effective. Strong CRCs anticipate problems before they occur, maintain meticulous documentation, and serve as advocates for both participant welfare and data quality. The position has become increasingly professionalized, with certification programs and professional organizations supporting career development.
Participant management
"The clinical research coordinator called the participant the day before each scheduled visit to confirm the appointment, remind them of fasting requirements, and answer any questions about what to expect."
Data management
"After each study visit, the CRC entered data into the electronic case report form, resolved any automatic edit checks, and filed source documents in the participant's study binder."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.