Ena Atarac-Simic

- briefing doctors/consultants on conducting the trial - setting up study centres - monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis - verifying that data entered on to the CRFs is consistent with patient clinical notes, source data verification - writing visits reports - filing and collecting trial documentation and reports - ensure all unused trial supplies are accounted - closing down study centres on completion of the trial

Responsibilities: - developing and writing trial protocols - managing regulatory authority applications and approvals, who oversee the research and subjects - briefing doctors/consultants on conducting the trial - setting up study centres, which includes ensuring each centre has the trial materials - monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis

Responsibilities: - Support of the RCTM / TCM during study preparation - Quality check of documents in close cooperation with CRAs - Ensuring trials documents provided on a regular basis from CRAs/CROs - Compilation and maintenance of the Clinical Trial Master File, collection and filing of clinical trial documents, scanning, quality check of scanned versions, and archiving of documents into IDEA for SUB - Handling of correspondence with trial members ( TMM, TCM, RCTM,CRO/CRA )

Responsibilities: - Maintainanceof manual and electronic documents files and records (e.g. department databases, calendars, work orders, timesheets/Interflex -WebClient, expense reimbursement requests/SAP-SRM) - Maintanance of safety documentation including arhiving, tracking, retrieval - Prepares a variety of correspondence, reports and other materials (presentation slides) - Learning One Source (LOS) Department Key User

Responsibilities: - Screening incoming calls and e-mails, setting appointments with employees - Coordinating meeting times, scheduling conference room facilities, booking off-site meeting locations, sending out invitations, writing and distributing agenda - Paper and electronic record management (Interflex – WebClient; SAP/SRM), setting up and managing spreadsheets, compiling information and producing minutes/reports

Anthropology