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Observational Specialist II

Parexel International Corporation

Spain - Any Region - Home Based

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.

This role is decentralised in the Spain.

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.QualificationsSkills

•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

•Fluent in written and oral English.

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.

Job posted: 2022-05-21

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