CRA Trainee 临床监查员培训生
昆泰医药发展（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2014-07-23
- 工作地点：长春
- 招聘人数：若干
- 工作经验：一年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位月薪：面议
- 职位类别：临床研究员
职位描述
欢迎有医药相关教育背景，英语口语良好，能吃苦耐劳，勤奋工作者应聘！有少量CRA经验或临床研究领域相关经验者均可应聘！
面试合格者预计在2014年9-10月入职参加培训。
RESPONSIBILITIES
?
Complete appropriate therapeutic, protocol and clinical research training to
perform job duties.
? Gain experience in study procedures by working with
experienced clinical staff in Clinical Research Associate (CRA),
Clinical
Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work
collaboratively with other functional
groups such as data management and
pharmacovigilance.
? Under close supervision, perform site selection,
initiation, monitoring and close out visits in accordance with
contracted
scope of work and good clinical practices.
? Under close
supervision, administer protocol and related study training to assigned sites
and establishes regular lines of
communication with sites to manage ongoing
project expectations and issues.
? Under close supervision, evaluate the
quality and integrity of study site practices related to the proper conduct of
the
protocol and adherence to applicable regulations. Escalate quality issues
to CTL and/or line manager.
? Under close supervision, manage the progress of
assigned studies by tracking regulatory submissions and
approvals,
recruitment and enrollment, Case Report Form (CRF) completion and
submission, and data query generation and
resolution.
? Under close
supervision, create and maintain appropriate documentation regarding site
management, monitoring visit, findings and action plans by submitting regular
visit reports and other required study documentation.
All responsibilities
are essential job functions unless noted as nonessential (N).
REQUIRED
KNOWLEDGE, SKILLS AND ABILITIES
? Basic knowledge of applicable clinical
research regulatory requirements; i.e., Good Clinical Practice (GCP)
and
International Conference on Harmonisation (ICH) guidelines
? Computer
skills including proficiency in use of Microsoft Word, Excel and PowerPoint and
use of a laptop computer
? Strong written and verbal communication skills
including good command of English language
? Excellent organizational and
problem-solving skills
? Effective time management skills
? Ability to
manage competing priorities
? Ability to establish and maintain effective
working relationships with coworkers, managers and clients
公司介绍
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY