Site Coordinator is health-care professional who works under the direct supervision by PI or/and Sponsor/CRO for the purpose of conducting Clinical Trials. One site, have one site coordinator.
Site coordinator is working in every stage of clinical trial.
In start-up stage site coordinator is key contact for start-up team (Sponsor and CRO). He/she helps with preliminary budget and CTA review. Of course, keep Sponsor/CRO in the loop on any resource change at the site. Assures external legal support will be given to the site for the case of CTA review delays (lack of resources, huge workload and lack of expertise). He/she has responsibility for drug release documents prepare, completion and signature (CVs, FDA 1572, FDFs). He/she must prepare and distributes specific documents for LEC and Regulatory agencies.
In site initiation stage site coordinator helps CRA for any activity, and makes sure to keeps site staff aware of upcoming initiation and assures their presence.
In recruitment and maintenance stage he/she helps PI with internal patient data base search, determine the best recruitment practice, give answers to PI and study staff related to ICF and questioners. Then, must take care about Investigator Site File from SIV to COV
Site coordinator organize space for study equipment and supplies at the site.
Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports and progress reports. He/she communicate with laboratories and investigators. And, he/she organizes data entry. In every stage helps CRA, and prepare site for monitoring and audit.
At close out visit, with CRA and Sponsor do all close out activities, and data cleaning and archiving.