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:2014-08-06
- 工作地点:成都
- 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
CRA Trainee项目是昆泰面对新人所设置的一个CRA专业人才培养项目,旨在通过昆泰的专业培训,培养输送合格的CRA到昆泰各个国际化项目中承担CRA的专业工作。
CRA Trainee在入职之初需要接受为期14周的全职培训。公司提供临床研究领域全球一流的培训资源,提供具有竞争力的薪资福利和专业的个人成长计划。
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经验或临床研究领相关经验者均可应聘!
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