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Administracja biurowa » Pracownik biurowy

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COVANCE is looking for Clinical Start-up Associate (GSS division) to b Nr ref.: /JOBS.pl Position: Clinical Start-up Associate (Global Site Services division) Location: Brussels Are you looking for a challenging and varied job in the world of clinical trials? Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries. Tasks and Responsibilities: ° Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan ° Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger ° Assist in preparation of project specific plans for the GSS component of assigned studies ° Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable ° Assist in review of core Country patient informed consents for compliance to country requirements and protocol as applicable ° Assist in review of investigative site specific patient informed consents for required elements ° Maintain and update document tracking information in the Trial Tracker™ Site Information Module and other tracking logs ° Assess impact of site persom1el changes on regulatory documents and process/review new documents according to GCP/ICH guidelines ° Assess impact of study amendments on Informed Consent and other study documents and revise and review accordingly ° Liaise with applicable IRB/IEC regarding investigator submission/approval issues as appropriate ° Setup and maintain investigative site files ° Understand and follow project specific and GSS policies and procedures ° Generate investigative site status reports for supervisor review ° Assemble administrative binders for study sites ° Perform other duties as assigned by management ° Assist in managing the drug supply vendor activities as applicable ° Assist in developing, review and approval drug supply labels as applicable ° Assist with the preparation and dissemination of feasibility documents according to the processes in place ° Assume responsibility for identifying key therapeutic area investigators and consultants for external feasibility ° Develop and populate response spreadsheets from returned surveys; tabulate data into summary tables for incorporation into formal feasibility survey reports ° Assume responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required ° Design and generate standard and complex query reports from various databases to support internal/client requests for information; develop and/or review time/cost reports for feasibility activities ° Responsible for identifying internal resources, locating critical historical data contained in feasibility and proposal archives, prioritizing requests for information from various internal databases and determining appropriate format for reporting same Profile: - University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) - Good organizational, time management and communication skills - Work well independently as well as in a team environment - Fluent English and local languages French and Dutch - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines would be an asset - Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills) Education/Qualifications Required: + University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work Experience in clinical research, including a strong working knowledge of the JCH guidelines and FDA, IRBIIEC regulations will be considered Experience Required: + Good organizational and time management skills + Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred + Good communication skills, oral and written + Self-motivation with the ability to work under pressure to meet deadlines + Works well independently as well as in a team environment + Detail and process oriented + Positive attitude and approach + Interact with internal and external customers with high degree of professionalism and discretion + Multi-tasking capability + Computer proficiency (MS Office- Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.). + Flexible and adaptable to a developing work environment EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us. Brussels, BEL Brussels, Belgium Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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