宜昌招聘

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 procedures
In 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:
o Providing input on study protocol, CRFs and other study documents
o Authoring or assisting in the creation of Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets
o Assisting in the creation of corrective and preventive action plans and trending reports
o Managing site assignments in collaboration with manager
o Facilitating communication and information flow between assigned project teams and assigned monitors on project
o Ensuring monitors are trained, current with project requirements and understand study milestones
o Overseeing action item tracking and resolution status
o Performing co-monitoring visits as needed
o Ensuring Monitoring Plan requirements are being met and escalates risks
o Attending Core/Study team meetings
______________________________________________________________________
BASIC QUALIFICATIONS:
EDUCATION REQUIRED:
?Degree in life sciences, nursing or other health related disciplines
YEARS OF EXPERIENCE
?Two (2) years Clinical Research experience
?One (1) year of Clinical Research monitoring preferred
________________________________________________________________
DESIRED/PREFERRED QUALIFICATIONS
?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: 8/29/2014
relationships, 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)
______________________________________________________________________
PHYSICAL JOB REQUIREMENTS:
?The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
?While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers
?Ability to travel up to 80%
?Travel with colleagues and manager as requested.
?May require international travel 举报 分享

About Medtronic
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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.

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