杭州招聘

Business Segment

Healthcare Science Technology

About Us

GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com

Role Summary/Purpose

The Clinical Research Associate (CRA) supports the Business Research Managers (RMs) 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

•Supports RMs in performing initial contact and participates in the assessment and selection of qualified investigators for inclusion in research.
•Supports RMs in completing Pre-Selection, Initiation, Monitoring, and Closeout site visits, or coordinate contractors in their performance of these activities as needed. Tracks required documentation from study site.
•Reviews and approves study documentation such as protocols, informed consents, amendments, case report forms, and study reports.
•Supports RMs with initiation of research and site training.
•Ensures compliant recording and reporting of any adverse events occurring during research.
•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.
•Assists with the coordination and conducting of the Research Review meetings.

Quality Specific Goals:
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

•Bachelor’s degree (or internationally recognized equivalent) in a science related field or R.N. with a minimum of 5 years’ experience with clinical applications, research management or regulatory affairs within the pharmaceutical or medical device industry OR minimum of 9 years progressive experience with clinical applications, research management or regulatory affairs within the pharmaceutical or medical device industry.
•Strong experience of all aspects of the clinical research process, including site selection, investigator qualifications, monitoring, protocol and report writing.
•Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
•Strong problem solving, influencing and negotiation skills; diplomatic team player
•Ability to travel up to 20% of time for responsibilities focused on research management and up to 75% for responsibilities focused on research site monitoring.

Desired Characteristics

•Demonstrated project management skills to prioritize, plan, delegate & evaluate deliverables; well organized and structured, attention to detail.
•Prior medical device experience.
•Experience interfacing with Regulatory Agencies such as FDA.
•Experience with Global research regulations.
•Auditing experience.
•Clinical trial professional certification, e.g. CCRP, CCRA or CCRN

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。