天津招聘

Business Segment
Healthcare Quality

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Role Summary/Purpose
The Clinical Research Associate (CRA) supports the Clinical Affairs Project Managers (CAPMs) and other team members as required through monitoring and coordinating of clinical research studies to ensure research is compliant with Good Clinical Practices and other applicable regulations and company procedures.

Essential Responsibilities
• Partners with CAPMs and project team members to perform initial contact with potential investigators and participates in the assessment and selection of qualified investigators for inclusion in research.
• Performs Qualification, Initiation, Monitoring, and Closeout site visits, or coordinate with contractors in their performance of these activities. Tracks required documentation from study site.
• Works with research site personnel to ensure all research activities are run compliantly and according to protocol.
• Perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and GCP/applicable regulatory guidelines. Help to define quality standards within the project team.
• Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports.
• Reviews ethics committee reports.
• Ensures compliant recording and reporting of any adverse events occurring during research.
• Produce timely and comprehensive visit and status reports. Serve as Subject Matter Expert in the completion of thorough and accurate trip reports.
• Interfaces with Regulatory Agencies as required.
• Ensures overall regulatory compliance of investigational sites with applicable regulations.
• Reviews clinical history file for completeness throughout research process.
• May be involved with Research process improvement activities/projects as well as Corrective and/or Preventive actions tied to Research process.
• Depending on country/region location, assist with the collection of high quality documents required for study start and completion of ethics committee and regulatory submissions as applicable.
• Perform office-based project tasks as needed, including but not limited to: reviewing and evaluating regulatory/project documentation, contacting study site staff, providing project progress updates, developing tracking tools for deliverables, assisting other functional departments with project-specific tasks, etc.
1. Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures.
5. Assist with continuous improvement activities by driving the implementation of process improvement initiatives

Qualifications/Requirements
1. Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. with a minimum of 2 years experience with clinical research, OR minimum of 6 years progressive experience with clinical research.
2. Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)
3. Ability to travel up to 70% of time for job related responsibilities.

Desired Characteristics

1. Experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail.
2. Clinical trial professional certification, e.g. CCRP, CCRA or CCRN.
3. Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.
4. Regulatory Affairs Certification (RAPS).
5. Knowledge of Quality Management Systems (QMS).
6. Experience working across cultures/countries/sites.
7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
8. Demonstrated ability to work well independently & in a team setting.
9. Strong problem solving, influencing and negotiation skills.
10. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.

通用电气（GE) 公司是一家全球领先的科技、服务和金融公司，是全球最大的多元化企业，致力于解决世界上最棘手的问题。GE的产品和服务范围广阔，从能源、石油天然气、水处理、航空、医疗、运输系统、家电、照明，到金融，客户遍及全球100多个国家，拥有30多万员工。杰夫?伊梅尔特先生是现任董事长及首席执行官。

GE公司的历史可追溯到托马斯?爱迪生，他于1878年创立了爱迪生电灯公司。1892年，爱迪生通用电气公司和汤姆森－休斯顿电气公司合并，成立了通用电气公司（GE）。GE是道 琼斯工业指数1896年设立以来唯一至今仍在指数榜上的公司。

2011年GE的年销售达1420亿美元。

GE现有6个产业部门，其中包括：航空、交通运输、医疗、能源、GE金融、家庭和商业解决方案。

GE (NYSE: GE) is Imagination at Work – an advanced global technology, service and finance company that is taking on the world’s toughest challenge. Widely recognized as the world’s largest multi-business company, GE excels in a variety of sectors including energy, oil and gas, water treatment, aviation, healthcare, transportation, lighting, appliances and finance. GE serves customers in more than 100 countries and employs more than 300,000 people worldwide. Jeffrey R. Immelt is Chairman of the Board and Chief Executive Officer of GE.

The company traces its beginnings to Thomas A. Edison, who established Edison Electric Light Company in 1878. In 1892, a merger of Edison General Electric Company and Thomson-Houston Electric Company created General Electric Company. GE is the only company listed in the Dow Jones Industrial Index today that was also included in the original index in 1896.

Total revenue of GE reached $142.0 billion in 2011.

GE is having six businesses including: Aviation, Transportation, Healthcare, Energy, GE Capital, Home and Business Solutions.