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Medex Smo is seeking a Site Coordinator to support clinical trials under the supervision of the Principal Investigator. You will plan daily activities, ensure protocol and GCP compliance, and facilitate sponsor and stakeholder communication while safeguarding data integrity and volunteer safety.
Responsibilities include assisting in screening volunteers, organizing visits, preparing procedures, handling specimen logistics, and ensuring accurate study documentation.
The Site Coordinator is responsible for the effective management and conduct of clinical trials under the supervision of the Principal Investigator. This role includes planning daily activities, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP). The Site Coordinator facilitates communication between the sponsor, internal and external stakeholders, and ensures the secure collection of study data, the protection of volunteer safety, and compliance with regulatory requirements.
If required, reviewing hospital files under supervisionof principal investigator in order to help preliminary volunteer screeningprocedures in the recruitment period, should all necessary permits areobtained, and making efforts to find eligible volunteers,
Providing help to the study personnel who isassigned in the trial in screening volunteers who are deemed eligible to thetrial protocol by the principal investigator (appointment organization ofvolunteers, helping the study personnel assigned in the trial in noninvasiveprocedures which are authorized by the principal investigator),
Organizingand monitoring appointments in order to make volunteer visits are performed intimely manner,
Making necessary preparations in order to helpthe principal investigator perform procedures in accordance with the trialprotocol during visits (for example, making list of procedures to be performedand reminding them to the principal investigator or other investigators),
Sendingblood samples drawn from volunteers to central or local laboratory as per thetrial protocol, organization, tracking of courier procedures, monitoringlaboratory reports, making the investigator examine reports, filing reports,informing those concerned for taking immediate measure if there is a remarkableor labeled abnormal finding in the report,
Providing help in recording information of volunteers completely to reference documents (patient file, study file) of thehospital,
Making the investigator evaluate and undersigndocuments such as laboratory results, ECG examinations, IVRS confirmation faxesand scales, which are amended specifically for the study, in a complete andtimely manner and if required, making them filed
Taking necessary measures in order to ensureadequate amount of study materials, patient diaries, laboratory kits, patientidentification cards and is available throughout the study,
Relevant form for safety notifications which fulfilldefinition of serious adverse event reported by the volunteers is filled in bythe investigator and it is immediately notified to the sponsor and monitoringsuch events (for example, discharge reports of patients, hospitalizationrecords or supplying death reports),