浏览原职位详情
- 职位介绍
- 职责描述： • Participates in site feasibility and/or pre-trial site assessment visits, providing， recommendation from local area about site/investigator selection in collaboration with the trial team. • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. • Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team. • Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g…,OSQMV. 任职要求： • A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate＇s eligibility. • Specific therapeutic area experience may be required depending on the position. • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. • Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home. • Proficient in speaking and writing the country language and English. Good written and oral communication skills.
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