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 trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.This is a Remote (work from home) position.Some of what you will do :Identify investigator sites and participate in the feasibility process for new studiesPerform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCPPerform visits remotely according to foreseen applicable procedures and timeframesInteract with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submissionWork 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 targetsCheck the correct submission and completion of informed consent formsManage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolutionVerify that serious adverse events have been reported using a SAE form, according to OPIS and / or Sponsor proceduresMaintain 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 completionCreate 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 documentationRequirements :Enthusiastic, knowledgeable and proactiveUniversity degree in a scientific / life science fieldAt least 2 years of experience in managing and conducting clinical trialsIn depth knowledge of ICH GCP principlesAble to carry out independently all the activities related to the monitoring of clinical trialsGood knowledge of Office Suite (Word, Excel, PowerPoint)Organizational and problem-solving skillsExcellent written and verbal communication skills including good command of English languageFounded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.We offer a competitive salary with other benefits and opportunity to develop your professional career with an expanding and growing company.Candidate Privacy PolicyJ-18808-Ljbffr
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