Clinical Research Monitor 上海

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该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： POSITION RESPONSIBILITIES:? Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies? Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up? Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan? Identify site needs, provide solutions to facilitate the clinical trial process? Act as a primary point of contact for study sites as requested? Assist in initial and ongoing site personnel training as required? Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures? Collaborates with monitoring management and study team personnel towards securing Investigator compliance? Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)? Possess a working knowledge of disease state and investigational product? Possess understanding of regulatory requirements? Attend internal department and team meeting as requested? Adhere to all applicable Medtronic policies and proceduresIn addition, the Clinical Research Monitor may:Last Updated: 8/29/2014? Attend Investigator and/or Coordinator meetings? Provide input into final study site selection? Be involved in site management activities? Be assigned lead monitor responsibilities which include but are not limited to:? Providing input on study protocol, CRFs and other study documents? Authoring or assisting in the creation of Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets? Assisting in the creation of corrective and preventive action plans and trending reports? Managing site assignments in collaboration with manager? Facilitating communication and information flow between assigned project teams and assigned monitors on project? Ensuring monitors are trained, current with project requirements and understand study milestones? Overseeing action item tracking and resolution status? Performing co-monitoring visits as needed? Ensuring Monitoring Plan requirements are being met and escalates risks? Attending Core/Study team meetingsPREFERRED QUALIFICATIONS：?Degree in life sciences, nursing or other health related disciplines?Capable of clearly and effectively communicating verbally and in writing? Excellent interpersonal skills? Experience working in a team/matrix environment requiring strong working relationships? Ability to handle and prioritize multiple therapeutic areas and projects simultaneously? Ability to work in a fast paced environment? Competencies and essential skills in the following: cross functional Last Updated: 8/29/2014relationships, decision making, execution/results/process improvement, customer satisfaction? Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands? High attention to detail and accuracy? Excellent problem solving skills? Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)? Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)? Business knowledge or experience with the medical / healthcare industry? Class III medical device and/or phase II, III and IV pharmaceutical experience? Experience of conducting clinical research activities in a regulated environment? Proficient knowledge of medical terminology? Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)? Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training) 职能类别： 临床研究员 临床协调员 关键字： 医疗器械 临床监察 临床协调员

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About Medtronic Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others. We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

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