Clinical Research Professional for Astellas
Since July 2015
Working for Astellas Pharmaceuticals as Clinical Study Associate. The Clinical Study Associate will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial which can include: Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF). Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites. Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return. Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial Create & maintain study contact lists for team/sites/3rd parties/set up mail merges. Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis. Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study. Preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
Senior Clinical Trial Coordinator for MSD
September 2013 --- June 2015
Site correspondence, tracking SUSARs and PSURs/DSURs and sending them to sites and EC's. Collecting documents for submission packages to RA's and EC's. Update and maintain internal database for site compliance. Filing in eTMF, tracking in CTMS system. All other support tasks for CRA's and team leads/COM's.
Senior Clinical Project Coördinator
January 2011 --- August 2013
Provide support and assistance to project managers and project teams related to the assigned projects. Support all project-related activities for assigned projects in accordance with SOPs, policies and practices. Manage set-up and maintenance of all project documentation files, records and application files Coordinate all information and communication for assigned projects Update and maintain internal databases, tracking systems and project plans with project specific information Prepare and distribute status, tracking and project finance reports Prepare presentation materials for meetings ( internal/external) and project summary data Coordinate project team and customer meetings, identifying and planning appropriate medium ( web, telecon, f2f) and ensuring arrangements are handled appropriately. Determine and plan all meeting requirements in advance. Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly. Create and track timelines Coordinate with other project support staff within and across the Global Project Management Unit to identify and consolidate support processes. Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics. Serve as primary back-up contact for internal project team and for external stakeholders/customers as designated by project manager Assist the project manager with budget allocation and approval of invoices Undertake project management activities as directed by project manager Train and mentor junior support staff
Senior Clinical Trial Assistant (CTA)
September 2007 --- October 2010
Assist Global Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. May perform assigned administrative tasks to support team members with clinical trial execution
August 1985 --- September 2007
Handling prescriptions and dispensing medication, contact the doctor/ specialist if required regarding the prescription Ordering sufficient stock, billing Preparing specialised hand-made medication like creams and ointments, potions, suppositories, capsules, eyedrops and more. Providing information to clients regarding their medication Homeopathy, cosmetics (Vichy, Roc), specialised bandages, gauzes, incontinence- and stoma materials, needles, catheters, tubes, specialised nutrition. Advising regarding over the counter medication.
Shop-assistant in a photo store (side job)
January 1983 --- January 1986
in Medical Secretary, Pharmacy assistant from HAVO, Medical Secretary School, Pharmacy Ass. School in 1985