Innovaderm is currently looking for a Regulatory Affairs assistant.
· Prepare, manage and follow up on submissions to the Ethics Committee for the site;
· Is the primary point of contact for ethics committees; receives and processes communications / approvals.
· Complete and track the signatures of regulatory forms (ex: QIU, FDA1572, FDF);
· Follow up on approvals and translation of consent forms;
· Maintain regulatory record of studies;
· Ensures tracking of submission and renewal schedules and ensures they are met;
· Prepare and update the various documents necessary for the construction of the files of the persons involved in a research project (eg CV, attestation of training, etc.)
· Hold and update the investigator's binders;
· Responsible for the closure and annual renewal of ethics projects;
· Assist the Research Coordinator in communicating with the Sponsor and performing clerical duties;
· Participate in project-specific tasks as delegated by managers