Internal Medicine Team

Received Excellence in Project Delivery Award for 2016 and Golden Encore Award 2017. Completed CRA Training Program via Icon University. To ensure overall site management and adherence to internal SOPs, policies, ICH-GCP and local regulatory requirements using the following systems: ProPhase, Covance Lablink, ERT, PHT SitePad, Cogstate, Firecrest, Bracket, IATA.Accompanied site visits with monitors eg. Site Initiation Visit, Routine Monitoring Visit, Site File Review, Perform Investigational Product Destruction, Preparation for LHA inspection on site, Close out Visit, to participate in IM. Perform essential document collection by source data verification. Verifying Serious Adverse Event reporting and overall safety related events (AEs, endpoint events according to trial specifications and ICH GCP guidelines).Contract preparation and negotiation, using the ICD, Cornerstone systems, tracking the status of them.Assistance in regulatory submissions, using EUDRA CT, update the TMF with appropriate documentation and track regulatory documents.To collect and track all relevant site feasibility/country feasibility documentation and upload to V-TMF.To ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.Maintain site/country level informations in Medidata CTMS.Collect, review, and track investigational site staff training documentation.Collect and track Financial Disclosure information at appropriate time points.Prepare Site File and co-ordinate the development of other documents and review them for completeness and accuracy. Archive off-site paper TMF.Support the Manager in drug distribution process.Management of study data, budget, organizing meetings, mailing and correspondence.To contribute to site level recruitment strategy and contingency planning.Maintain and update CTSRS contact information to ensure appropriate SUA distribution.

As a Facilities Coordinator my responsibilities are the following:• Mobile fleet management over 200 subscriptions: contract negotiation and implementation of smart phones and MIFI devices. Key contact of our internal telecommunication specialist and Vodafone and Telekom representatives• Assist in the preparation of financial information as required by local and company accountants, including invoice processing, CAPEX and lease approvals. Ensure completion of tasks and resolve queries in a timely manner• Induction of new starters, organize trainings and business trips, staff events• Co-ordinate in sourcing and monitoring suppliers including ordering, stock control and distribution • Assist in the management of suppliers including quality service checks, contract reviews and negotiation in compliance with QA guidelines and company policies• Volunteer experience: Health and Safety Commitee member, Trained First Aider and Fire Marshall role. Participation in Business Continuity Management as BC Coordinator• Support the IT, Finance, HR, Procurement function at a local level, set up and coordinate all services for the staff • Provide operational cover in the absence of the Supervisor inculding: company car fleet management (over 70 vehicles), General support of Balkan Entities, Office management, Supervision of the local Facilities and Admin Team • Participation in internal and external audits. Advice and support managers and team leaders to promote highly engaged teams and to make the company a great place to work• Effective management of the Reception