The hospital clinical research assistant, or hospital clinical research technician works in direct collaboration with the investigator, who manages and supervises the clinical trials and medical teams at the hospital, within the treatment sites. He delegates various tasks of the study to her. Inlcuding:

  • Welcoming and advising subjects and volunteers.
  • Dealing with the findings of the study: filling and correcting the case report forms before they are validated by the investigator, registering adverse events (AE), preparing monitoring visits (providing the subjects’ medical files),
  • Ensuring and facilitating the handling of logistic and administrative aspects of the trial:  receiving and verifying the storage conditions of the required material for the study, such as documents, protocols, questionnaires, subjects’ consent form, and archiving at the end of the study,  
  • Ensuring efficient communication between the sponsor and the investigator: participation in implementation meetings and to other training meetings, collaborating with specialised departments as well as with the pharmacovigilance department, data management and the promoter’s project team.
  • Subjects’ follow-up: organising subjects’ appointments according to the schedule of visits, preparing and handling subjects’ questionnaires, helping the investigator for randomization (preparing the required elements), preparing biology kits, informing the analysis laboratory, preparing and sending tubes, and verifying the sample storage.

At CIC-IT, the clinical research assistant is specifically responsible for multidisciplinary work with protocols where MRI plays a central role. In addition to the previously mentioned task, she manages the database of healthy volunteers, organises their recruitment and plans the MRI roster.

She works closely with the clinical study coordinators and investigators, and participates in the writing of essential and practical documents for the current clinical studies: case report forms, information letter and consent forms, standard operating procedures (SOPs).