Assist clinical study team members in preparing, supervising and reporting of clinical trials in accordance with regulatory requirements and relevant standard operating procedures (SOPs)Set-up and maintain project filing for designated studies (paper and electronic filing systems for records)Assist in the preparation, correction, formatting of study-related documents (e.g. Protocol, Patient Information and Informed Consent Form etc.)Assist in preparation of presentations for study teams membersCollect, file and distribute study-related documents (e.g. preparation and maintenance of Trial Master File (TMF))Conduct searches for designated feasibility studiesAssist the study team members in implementation activities where required. Preparation, collection of Regulatory- and Essential Documents, facilitation of IRB/IEC submission and approval processPreparation of Investigator Site Files (ISF) e.g. for site initiationSet-up and maintenance of tracking systems, reliably and efficiently input data into the tracking systems to facilitate timely access by the study team members, e.g., patients, sites, essential documents, Serious Adverse Events, CRFs and data queries as required for assigned projectsParticipate in project team meetingsAssist in the preparation of meeting minutesCommunicate with the study team members and management and to take direction from them as appropriate.Exert administrative and secretarial functionsAnswer telephones and give information to callers, take messages or transfer calls to appropriate individualsDistribute incoming information to appropriate individualsArrange/coordinate appointments, conferences, meetings and events and welcome guestTake on any other task as assigned by Manager
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