FSP-CRA (哈尔滨)

Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Responsibilities and duties include, but are not limited to the following:

•Take charge of all aspects of Site Management as prescribed in the project plans.

•Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.

•Negotiate study budgets with potential investigators and collaborate with the Fortrea legal department with statements of agreements as assigned.

•Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

•Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.

•Assist with training, mentoring, and development of new employees, e.g. co-monitoring.

•Perform other duties as assigned by management.

职位福利：五险一金、年底双薪、补充医疗保险、带薪年假、定期体检、弹性工作