职位详情
CRA(FSP)
1.1-1.4万
君岳医药科技(上海)有限公司
北京
1-3年
大专
07-01
工作地址

朝阳区百环青创大厦

职位描述

In general, it provides site monitoring and
management services on DUA/RWE/PMS studies within MAO function and coordinate
the operational budget and resources across multiple tasks to ensure that studies
conduction meets performance targets and results.

- Arranging Site/Investigator Selection visit to assess
the eligibility of the site.

- Support on EC submission and approval before any
study activities.

- Acting as primary company contact for
assigned trial sites, engaging with Investigator and Site Staff throughout study
period. (Investigator meetings, site visits, study progress, issues/resolutions,
etc.).

- Proper training and communication to ensure
the study procedure and data collection requirement are well understood.

- Discussion of the recruitment plan and
study timeline with PI and site personnel to get alignment with targeted goal.

- Oversight of site study supplies and drugs/device/biologic
supplies to ensure the proper handling, storage and return with accurate
inventory and dispense records.

- ISF maintenance and ensuring secured
storage on site.

- Ensuring the data collection and query
resolution in a timely manner.

- Ensuring safety events are well documented
and timely reported per protocol requirement.

- Reporting of site progress
regularly and working with project leader on issues found on site in time and
providing updates until the issues are well resolved.


Metrics/KPIs: Metrics/KPIs governing these services are
based on the feedbacks from service- related stakeholders and project leaders.


Education and Experience Requirements:

· A minimum of a BA/BS degree, major in
Medicine/Nursing/Biomedicine are preferred.

· 1-2 years of relevant experience.

· Able to work effectively with all levels of the organization.

· Teamwork and collaboration

· Fluent in English reading and writing.

· Skillful at organizing and coordinating.

· Willingness to travel with overnight stay away from
home.

· Good time management skill.

· Good problem-solving skills and initiatives.

· Good computer skill (Word, Excel, Outlook, PowerPoint).

· Attention to detail.


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