Clinical Site Ambassador
4 giorni fa
Clinical Site Ambassador
Remote throughout Italy
In collaboration with Client, the Clinical Site Ambassador (CSA) is responsible for the developing and maintaining the relationship with the site. The CSA is the main point of contact for the site and will be responsible for knowing all aspects of the site capabilities and structure; being an expert on their sites. In addition, the CSA will perform all site management and monitoring activities at a clinical site(s). The CSA will ensure clinical studies are performed in accordance with study protocol, standard operating procedures and associated plans, and relevant local and internal regulations, legislation and ICH/GCP guidelines.
The CSA will serve as the single point of contact for the assigned sites for the lifecycle of the study in addition to developing and maintaining the relationship pre and post the study timelines. This includes, but not limited to feasibility, study-startup, essential document/TMF maintenance etc., in addition to supporting the site and other internal CSL functional areas such as Safety/Pharmacovigilance, Regulatory, Clinical Trail Supply, etc.
The CSA will be assigned clinical monitoring activities in a single country or in several countries ensuring appropriate clinical study conduct.
The CSA will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
The CSA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
The CSA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
The CSA will have to anticipate, recognize and resolve issues for the assigned study sites.
MINIMUM REQUIREMENTS: A minimum of 4 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred. For countries other than US and Canada, a minimum of 2 years of experience conducting and supporting RA/CA and IRB/EC submissions and regulatory document start-up activities. The ability to perform travel up to an average of 80%, depending on project needs. The candidate must have excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail. The candidate must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum. This role may be office and/or home-based/field-based however regular infrequent visits to a Company office will also be required. QUALIFICATIONS: Education: A degree (BSc/MSc) or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist) or approximately (5) years monitoring experience.
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