As a Clinical Research Associate (CRA), you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trials according to the study protocol, ICH-GCP, applicable regulations, guidelines, and sponsor requirements. Some of what you will do:
Identify investigator sites and participate in the feasibility process for new studies. Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., ICH GCP. Perform visits remotely according to foreseen applicable procedures and timeframes. Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission. Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets. Check the correct submission and completion of informed consent forms. Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution. Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures. Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion. Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation. Requirements:
Enthusiastic, knowledgeable, and proactive. University degree in a scientific/life science field. At least 2 years of experience in managing and conducting clinical trials. In-depth knowledge of ICH GCP principles. Able to carry out independently all the activities related to the monitoring of clinical trials. Good knowledge of Office Suite (Word, Excel, PowerPoint). Organizational and problem-solving skills. Excellent written and verbal communication skills including a good command of the English language. No restrictions to travel onsite. #J-18808-Ljbffr