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Senior CRA

We are currently looking for a Senior CRA to be office or homebased in Durham, NC or homebased in a city with strong transport links.

Job overview

The Senior CRA will implement and oversee projects in Ophthalmology, and ensure the quality of clinical trials. The Senior CRA will collaborate with the Director of Clinical Operations to review budgets and study plans, make changes where necessary, and manage projects together with the CRO, clinical monitoring team and clinical operations team. The Senior CRA will regularly visit clinical trial investigators to monitor and oversee the quality of the data, and will support the oversight of the CRO and clinical research associates. The Senior CRA will also support the writing of Clinical Study Reports, IRB annual reports and Investigator poster/presentations, as needed.

Essential functions

  • Collaborate with Director of Clinical Operations to set targets for clinical monitoring staff, and ensure the recording of trial in compliance with project goals.
  • Create and implement study-specific clinical monitoring tools and documents.
  • Create and oversee the trial budget.
  • Identify, enlist, and select sites, and coordinate site management activities.
  • Coordinate and supervise clinical monitoring team.
  • Provide CRAs with project-specific training and have regular meetings with them.
  • Arrange and oversee site visits.
  • Review of Monitoring Reports and Letters
  • Support oversight of CROs and vendors
  • Gather and exanimate trial documents.
  • Assure compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.

Qualifications

  • Bachelor’s degree in nursing or life sciences. Masters preferred.
  • 3+ years of work experience for a pharmaceutical company or related field.
  • Proficient understanding of ophthalmology studies and monitoring.
  • Excellent organization skills and ability to multi-task.
  • Outstanding communication skills, both verbal and written.
  • Proficient with Microsoft Office Word, Excel, and PowerPoint.
  • Ability to work independently and prioritize duties.
  • Understanding of Electronic Data Capture (EDC).
  • Available to travel.
  • Valid driver’s license.

To be successful in this role, the candidate needs to ensure the project meets the corporate goals within budget and on time. Top candidates are proficient multi-taskers with an ability to prioritize tasks.

Applications, with CV and covering letter, to Valentina Chiarelli, HR Manager, chiarelli@nicox.com.