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Clinical Trials Associate (FSP)

Parexel International Corporation

Hungary - Any Region - Home Based

Position Purpose:

Assist clinical study teams in the execution of clinical trials. Primary responsibilities may include establishing and maintaining the Trial Master File (electronic [eTMF] or paper TMF) and Clinical Trial

Management System (CTMS) in an inspection-ready state, reviewing and tracking essential documents throughout the life of the trial, and assisting with production and distribution of study materials and site communications.

Organizational Relationships:

• Reports to ExecuPharm (EP) Line Manager with day-to-day direction from the Client.

• Liaises with cross functional lines as appropriate.

Primary Duties:Establish and maintain the Trial Master File (system or file room) in an inspection-ready stateCommunicate directly with sites to drive collection of essential documents from start-upthrough study closureEnsure accurate and timely review and filing of clinical trial related materialsPerform and support QC reviews of study, country and site files, including issue resolutionProduce reports and status metrics as requestedEstablish and maintain the CTMS System in an inspection-ready stateMaintain accurate and up-to-date site, vendor and internal study team contact informationTrack study progress and produce reports and status metrics as requestedAssist with Investigational Product reconciliationAssist study team by performing administrative tasks as neededSchedule and run meetings, both in-house and remote by means of virtual conferencing systemPrepare meeting agendas, minutes, and track action itemsOperate and navigate within clinical trial systems including but not limited to TMF, CTMS, ECMS (document repositories), EDC (Electronic Data Capture)May assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reportsEnsure timely distribution of clinical trial related materials to sites, study team, field Clinical Research Associates (CRAs) and vendorsUnder the supervision of the Protocol Lead, may assist with the following:Perform limited data cleaning activitiesReview Informed Consent documentsPerform Site/Site Management Organization Regulatory MonitoringAssist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspectionsWorks under general supervision in performing regular job duties and receives general instructions on new assignmentsPrimarily works and collaborates with Protocol Lead, internal and external study staff, vendor staff, and peersAdhere to CFR, GCP/ICH, Clinical Development Operations and project-specific quality documents (e.g., SOPs, work practices, training guides)Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.Adheres to EP and Client SOPs and processes.QualificationsBS/BA or equivalent experience preferredA minimum of 1-year clinical trial experience, preferably within the pharmaceutical or biotechnology industryBasic knowledge and understanding of Essential Documents, CFR and GCP/ICHProficiency with technological systems (Microsoft Office, TMF, CTMS, EDC, ECMS, Zoom)Fundamental understanding of filing systems and organizational tools

Job posted: 2021-03-18

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