临床监查员CRA--疫苗Vaccine

该职位来源于猎聘 * 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

•* Acts as primary local company contact for assigned sites for specific trials. •* Attends/participates in investigator meetings as needed. •* 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. •* Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.

•* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. * Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct. •* 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. •* Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints). Profile: •* A minimum of a BA/BS degree is required.

A degree in a health or science related field is preferred.

•* Must have experience in Clinical Research or equivalent qualification •* Usually 0-2 years’ experience monitoring on site •* 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.