宜昌招聘

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

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？ Attend internal department and team meeting as requested

？ Adhere to all applicable Medtronic policies and procedures

In addition, the Clinical Research Monitor may:

？ 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

EDUCATION REQUIRED:

？ Bachelor’s Degree in life sciences, nursing or other health related

disciplines

YEARS OF EXPERIENCE

？ Two (2) years Clinical Research experience or Master’s degree and no

experience required

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.