Clinical Research Associate (m/f)

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About the position:

Study Start-Up Activities:

  • Assists the study team(s) to deliver the clinical study within agreed timelines
  • Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors (e.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
  • Provides oversight of Clinical CRO Investigator background checks
  • Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary
  • Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP
  • Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items
  • Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager
  • Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System
  • Assists and/or participates in planning and conduct of Investigator?s Meetings as necessary

Study Maintenance Activities:

  • Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced
  • Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager
  • Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present
  • Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements

Study Close Out Activities:

  • Assists study team with preparation for audits/inspections
  • Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager
  • Liaises with Transparency group to ensure and results are updated/distributed accordingly

Other tasks:

  • Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval
  • Maintains knowledge and acts as team super user or subject matter expert for related systems and processes
  • Maintains up to date training record attending internal/external training(s) as necessary
  • Participates in inter-departmental workgroups to create or enhance processes

Skills you need:

  • Bachelors degree required
  • 1-3 years experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor, Clincal Coordinator, etc.)
  • Available for up to 10% domestic and/or international travel
  • Relevant experience in clinical research or related field
  • Adequate Good Clinical Practice training
  • General knowledge of regulatory requirements and guidelines governing clinical research
  • Comfortable with technology and ability to learn new systems quickly
  • Strong knowledge of MS Word, Excel, PowerPoint and Outlook
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
  • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
  • Ability to work successfully within a cross-functional team

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary  according to collective agreement for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.


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