位于广州市的 6 个优质audit职位（正在招聘！）

FSP SCRA(Guangzhou)
Fortrea —广州市
- 全职
Lead, AI Platform- AI Factory
Standard Chartered —广州市
Senior AI Engineer
Standard Chartered —广州市
3天
Head, AI Engineering
Standard Chartered —广州市
8 小时
SR MANUFACTURING ENGINEER
TE Connectivity —佛山市
STAFF MANUFACTURING ENGINEER
TE Connectivity —佛山市

More jobs to discover

Find similar jobs that you might be interested in.

Lead, AI Platform- AI Factory
Standard Chartered —广州市
The ability to identify key issue and develop new feature for the platform. Responsible for developing new feature for AI Platform, ensure high availability of…
Head, AI Engineering
Standard Chartered —广州市
The Head of AI Engineering leads the engineering organization responsible for the bank's AI factory platform, providing end-to-end ownership of platform…
8 小时

我想收到关于广州市的 audit 的最新职位提醒

一旦登录您的账户，即表明您同意 SimplyHired 的服务条款和我们的Cookie 协议及隐私政策。

查看更多地区的职位

audit jobs near 广州市

位于上海市的Fpga Engineer职位

位于浙江省的Equipment Engineer职位

位于天津市的Senior Manufacturing Engineer职位

位于上海市的Optical Metrology Engineer职位

位于苏州市高新区的Software Engineer职位

位于北京市的Senior Software Engineer职位

位于苏州市的Ai Developer职位

位于上海市的Ai Agent职位

位于深圳市的Front End Developer职位

位于北京市朝阳区的Ai职位

FSP SCRA(Guangzhou)

Fortrea -
广州市

立即申请

职位详情

全职

完整职位描述

Job Overview:

The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

Summary of Responsibilities:

The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
General On-Site Monitoring Responsibilities:
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data.
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
Ensure audit readiness at the site level.
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports.
Manage small projects under the direction of a Project Manager/Director as assigned.
Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
Review progress of projects and initiate appropriate actions to achieve target objectives.
Organize and make presentations at Investigator Meetings.
Participate in the development of protocols and Case Report Forms as assigned.
Participate in writing clinical trial reports as assigned.
Interact with internal work groups to evaluate needs, resources, and timelines.
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsible for all aspects of registry management as prescribed in the project plans.
Undertake feasibility work when requested.
Conduct, report, and follow-up on Quality Control (QC) visits when requested.
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
Track and follow-up on 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.
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) Perform other duties as assigned by management.
All other duties as needed or assigned.

Qualifications (Minimum Required):

University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
Thorough understanding of the drug development process.
Fluent in local office language and in English, both written and verbal.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Three (3) years of Clinical Monitoring experience.
Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
Advanced site monitoring skills.
Advanced study site management skills.
Advanced registry administration skills.
Ability to work with minimal supervision.
Good planning and organization skills.
Good computer skills with good working knowledge of a range of computer packages.
Advanced verbal and written communication skills.
Ability to train and supervise junior staff.
Ability to resolve project-related problems and prioritizes workload for self and team.
Ability to work within a project team.
Works efficiently and effectively in a matrix environment.
Valid Driver's License.

Preferred Qualifications Include:

One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Local project coordination and/or project management experience.

Physical Demands/Work Environment:

Travel requirements: 60-80% overnight.

Learn more about our EEO & Accommodations request here .

立即申请

完善您的搜索

在广州市的audit个职位

FSP SCRA(Guangzhou)

Lead, AI Platform- AI Factory

Senior AI Engineer

Head, AI Engineering

SR MANUFACTURING ENGINEER

STAFF MANUFACTURING ENGINEER

More jobs to discover

我想收到关于广州市的 audit 的最新职位提醒

查看更多地区的职位

求职者工具

雇主工具

浏览

保持联系

完善您的搜索

在广州市的audit个职位

Lead, AI Platform- AI Factory

Senior AI Engineer

Head, AI Engineering

SR MANUFACTURING ENGINEER

STAFF MANUFACTURING ENGINEER

More jobs to discover

我想收到关于 广州市 的 audit 的最新职位提醒

查看更多地区的职位

我想收到关于广州市的 audit 的最新职位提醒