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Reference: 117 24/11/2021 18:56:07

Senior Clinical Research Associate.

United States Competitive Package

This position provides a fantastic opportunity to lead clinical activities for an orthopedic & spinal manufacturer launching a new clinical research program for emerging technologies.

In this position, you will be responsible for the management of assigned investigator sites and all monitoring activities for assigned studies. As a growing company, the position will provide scope to learn new skils and embark on a pathway to Clinical Program Management functions (aiming to include operations and trial design in the future)

The company is a unique manufacturer with an array of medical devices for spine surgery. With the aim of expanding with digital solutions (navigation & AR), the company are driven to create a best-in-class clinical research program for its implants. This position is integral to that, reporting to the Director of Clinical Affairs, with additional flexibility on location.

Key Responsibilities

  • Oversees contract research organization (CRO) personnel site activities and overall vendor performance.
  • Supports the development of clinical study plans, presentations, study documents, contracts, development and design of CRFs.
  • Leads review of clinical data listings for completeness and accuracy and escalates issues to the CPM or above as appropriate.
  • Provides co-monitoring and other shadowing opportunities to junior members of the team for training and development purposes.
  • Develops and implements enrollment and recruitment strategies.
  • Maintains a high level of professional expertise through familiarity with scientific literature, product portfolio and competitive environment.
  • Builds and maintains great working relationships with KOLs and Study PIs.
  • Reviews monitoring visit reports and tracks resolution of action items.
  • Identifies noncompliance and implements preventative and corrective actions.

Desired Experience

  • 3+ years' work experience in clinical operations related functions (Trial Coordinator, CRA etc)
  • 2+ years' experience in Clinical positions for orthopedics OR spinal devices.
  • A succesful work history in independent site management & data monitoring
  • Experience in site identification is a plus.
  • Medical device experience is essential.
  • Study start-up experience would be of great interest. 

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Consultant.

Daniel Spencer
Daniel Spencer
Associate Director  View Profile

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