Site Executive,GCTO（CRA）（上海） (职位编号：1)

· Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Performs source document verification of subject data and query resolution. Coordinate receipt and distribution of clinical trial supplies.

· Provides input to Site Selection utilizing site evaluation and validation processes.

· Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

· Manages a full complement of sites with multiple protocols, depending on study/site complexity. Discusses the need for escalation of site performance issues with CRM, and supports audit/inspection activities as needed.

- Requirements

· Medical qualifications, bachelor＇s degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science.

· Work with high quality and compliance mind-set.

· Proficiency in computer skills.

· Result oriented.

· Teamwork spirit and cooperation skills.

· Customer focus.

· Good communication skill.

· Proactive and self-motivated.