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PPD Development (S) Pte. Ltd | [此公司所有职位] |
SENIOR / Clinical Research Associate | [查看更多类似职位] |
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工作地点 |
北京 |
发布日期 |
2008-05-30 |
工作年限 |
1年经验 |
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薪水范围 |
面议 | 学历要求 | 本科 |
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| 职位描述 |
职位类别： 生物/制药/医疗器械 工作地点： 北京 发布日期： 2008-05-29 工作经验： 1-3年 最低学历： 本科 管理经验： 否 工作性质： 全职 招聘人数： 1人 职位描述/要求： POSITION PROFILE SENIOR / Clinical Research Associate Line Manager: Clinical Operations Manager or Assistant Clinical Operations Manager Functional reporting: Clinical Team Manager, Project Manager Basic Purpose and objective: Performs and coordinates all aspects of the clinical monitoring process in accordance with ICH GCP and FDA guidelines and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Responsible for ensuring that data will pass international quality assurance audits. Represents PPD Development in the global medical research community and develops collaborative relationships with investigational sites. Position scope: Serves as a primary contact with individual investigational sites that conduct clinical trials. Successful site management contributes directly to operational objectives, which in turn have an impact on project profitability. Goal is to deliver clean CRFs from an ICH GCP and SOP/WPD compliant process on time and within budget. Supervisory responsibilities: This position has no direct supervisory responsibilities Duties and Responsibilities (according to relevant guidelines, laws and SOPs) Identify potential investigators in collaboration with the sponsor. Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted Perform monitoring duties as specified in the relevant procedures Verify data versus source documentation and validate CRF entries Generate and resolve queries as required Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable. As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study prepare Regulatory Compliance Review packages Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc Organise and participate in investigator meetings as necessary Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager Administer investigator payments Conduct and ensure proper trial close out and retrieval of trial materials Archive relevant documents as per procedures Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of project management, clinical team management and clinical operations management in writing Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts Facilitate and respond to company, client and regulatory audits Contribute to the project team by mentoring new members, assisting in preparation of project tools and sharing ideas and suggestions with team members. Qualifications: Bachelor"s or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience Valid passpor Skills and knowledge: Effective oral and written communication skills Excellent interpersonal skills Strong attention to detail Basic computer skills and the ability to learn appropriate software Good English language and grammar skills Basic medical/therapeutic area knowledge and medical terminology preferred Ability to work in a team or independently as required Ability to travel and spend 60 to 80% of working week at site. Experience: A minimum of one year experience as a Clinical Research Associate / monitor or in a health sciences field / clinical research setting is preferred, although some trainee positions are available. Three years" experience for the Senior CRA role 联系方式： Please indicate the position you are applying for. Please send your resume only in plain text. Please write/paste all words in body of e-mail, DO NOT attach any files. Please indicate that you are responding to Zhaopin.com! .
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