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Home Based Opportunities at Parexel

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Senior Observational Research Specialist

求人ID 57054BR ロケーション スペイン 仕事内容

Observational Research Specialist provides site management for observational/non-interventional research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:

◦Site identification
◦Negotiation of site agreements and budgets
◦Collection and review of regulatory documents for EC and RA submissions
◦Customization of informed consent
◦Site management

Additional responsibilities include review of eDC data. The ORS is accountable for site satisfaction and issue resolution or appropriate issue escalation.

Key Accountabilities
•Primary contact for assigned sites
•Perform site start-up activities
•Demonstrate protocol expertise
•Conduct remote visits (initiation, monitoring, termination)
•Train team members on selected tasks
•Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC,IVRS, ISIS)
•Responsible for the completeness and quality of the in-house site specific files (in cooperation with ROA/RMA)
•Update all relevant tracking systems on an ongoing basis
•Follow-up on appropriate site related questions

Qualifications

Skills
•Sound interpersonal, oral and written communication skills
•Strong computer skills including Clinical Trial Management Systems, Electronic records, EDC, MS-Office products such as Excel, Word and PowerPoint.
•Strong awareness of all relevant regulations, including GCP and GPP
•Ability to successfully work in a (‘virtual’) team environment
•Strong knowledge of observational/non-interventional study research
•Sound problem solving and analytical skills
•Strong customer focus, ability to interact professionally within a client organization and with study sites
•Willing and able to travel as required – local or international.

Education
•Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience

Language Skills
•Competent in written and oral English and Spanish

Minimum Work Experience
•Previous clinical monitoring (on-site or remote) data management and/ or research experience with a solid understanding of observational/non-interventional research methodology and terminology
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