该职位来源于猎聘 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 Fortrera 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. 【Education/Qualifications】
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). 【Experience】
- Full experience in PSV, SIV, RMV, COV in chemical drug, phase II/III.
- 1~3 years CRA experience for CRA I. For reference only
- 2~4 years CRA experience for CRA II. For reference only
- At least 4 years CRA experience for SCRA. For reference only
- Oncology study experience is highly preferred.
- Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- English workable is a MUST.