Big Leap Clinical Research Support Company Limited – Project Lead

02/05/2018

Thông Tin Tuyển Dụng

Nơi làm việc:

TP. Hồ Chí Minh

Mức lương:

Thỏa Thuận

Số lượng tuyển dụng:

Thời hạn nhận hồ sơ:

31/05/2018

Yêu cầu công việc

Mô tả công việc:

To provide general administrative support to the SSD and assistance to Clinical Research Manager
To assist the Clinical Operations Teams in SSD in completion of all required tasks to meet departmental and project goals.
To support the Clinical Operations teams with ongoing conduct of studies
To be familiar with ICH GCP, appropriate regulations, relevant SSD SOPs and SSD internal tracking systems
To assist Project teams with study specific documentation and guidelines as appropriate
To set up, organize and maintain clinical study documentation (e.g. Study Files, CRFs, etc.), including preparation for internal/external audits, final reconciliation and archives.
To process Data Collection Forms e.g. log in, tracking, quality control, as appropriate for the study.
To assist in quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.).
To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate
To assist project teams with trial progress tracking by updating the Clinical Trial Management Systems.
To copy and file incoming correspondence, internal documentation, CRFs, etc. as appropriate.
To assist in co-ordination of Investigator payments, if applicable.
To contact clinical sites for specific requests (e.g. enrollment, updates, missing documentation, meeting arrangements, etc.).

To assist in the tracking and distribution of reports.
To co-ordinate document translation, if required.
To attend project team meetings and generate meeting minutes.
To assist the Manager and Project team with meeting coordination, activities preparation and generate meeting minutes.
To assist in the production of slides, overheads, etc. as needed for project, department, sponsor and/or business development presentations.
To assist with the coordination of team member tracking.
Other duties as assigned.

Experience, Skills, Knowledge Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or ability required.
Research or health care related academic or work experience preferable.
Good organization skills, ability to manage multiple tasks and meticulous attention to detail.
Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
Foreign language skills desirable.
Good oral and written communication skills.
Willingness to travel for job related activities if required (expected travel for this position is < 20%).

Education Requirements

Thông tin khác

Thời gian phản hồi kết quả phỏng vấn (dự kiến):

2 – 3 ngày

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