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Senior Clinical Research Specialist

MinneapolisMedtronic


POSITION DESCRIPTION:

The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.

POSITION RESPONSIBILITIES:
  • Prepare and revise study materials and/or training
  • Conduct training of site and/or Medtronic staff
  • Assist in site initiation activities (e.g. study start-up documentation preparation)
  • Set-up and maintain accurate progress and study status tracking logs
  • Assist in the preparation of reports, regulatory submissions, publications and presentations
  • Assist in the preparation of budgets and project plans
  • Identify and mitigate quality risk and/or issues associated with assigned studies/activities
  • May arrange conference calls, staff meetings, and training events.
  • Assist in the preparation and review of data
  • Oversee follow-up and resolution of sites issues
  • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines
  • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks
  • Contribute to process improvement initiatives and participate in training to enhance knowledge

    POSITION DESCRIPTION:

    The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.

    POSITION RESPONSIBILITIES:
  • Prepare and revise study materials and/or training
  • Conduct training of site and/or Medtronic staff
  • Assist in site initiation activities (e.g. study start-up documentation preparation)
  • Set-up and maintain accurate progress and study status tracking logs
  • Assist in the preparation of reports, regulatory submissions, publications and presentations
  • Assist in the preparation of budgets and project plans
  • Identify and mitigate quality risk and/or issues associated with assigned studies/activities
  • May arrange conference calls, staff meetings, and training events.
  • Assist in the preparation and review of data
  • Oversee follow-up and resolution of sites issues
  • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines
  • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks
  • Contribute to process improvement initiatives and participate in training to enhance knowledge

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