Role descriptions
- Country coordinator (or CSM)
- A country coordinator is responsible for the monitoring team in one country (or region). He or she is working with the sponsor (or sub-contracted CRO). He or she is overseeing the monitoring activities within the country/region.
- Laboratory contact
- A laboratory contact is a person working in or in close collaboration with the pathology laboratory at the site. This role can include (but is not limited to) sample collection, handding, storage, shipping and tracking.
- Monitor
- The main function of a monitor or clinical research associate (CRA) is to monitor the clinical trial. He or she may work directly with the sponsor, for a Contract Research Organization (CRO) or for an (academic) research organization. He or she ensures compliance with the protocol, checks site activities, makes on-site visits, reviews Case Report Forms (CRFs), performs Source Document Verification (SDV) and communicates with investigators.
- Principal investigator
- The principal investigator has absolute responsibility for the overall conduct of the trial in a site, including but not limited to medical, financial, regulatory compliance, translational sample collection and tracking, electronic data submission (eCRF) and administrative aspects.
- Study coordinator
- A study coordinator is responsible for conducting the clinical trial at the site, in compliance with good clinical practice (GCP), under the auspices of the Principal Investigator. This role can include (but is not limited to) informed consent collection, recruitment, patient care, ensuring protocol compliance, regulatory compliance, translational sample collection and tracking, electronic data submission (eCRF), and administrative aspects. This job profile is also called 'research nurse'.
- Sub-investigator
- A sub-investigator is a researcher in a clinical trial or clinical study. It's a member of the medical clinical trial team designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions and who has the authority to sign Case Report Forms (e.g., associates, residents, research fellows).