Senior Clinical Research Associate

Location: United States (Remote)
Job ID: 1007

Position Overview

With this opportunity, you’ll join a team of diverse and dedicated problem solvers, continuously challenging each other to bring forward diverse perspectives and insights that ignite innovation and make a difference to the work that we do. We are seeking a highly motivated professional who is looking to grow their career with our company.

As a Senior Clinical Research Associate, you will be part of a growing team and be responsible for all aspects of clinical trial site visits, monitoring and management in North America (USA & Canada). The successful candidate will maintain appropriate documentation regarding site management, monitoring visit findings and creating actions plans where required.

Responsibilities and Work You'll Be a Part of

  • Conduct Pre-Selection Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close-Out Visit (COV) at assigned sites in accordance with contracted scope of work and Good Clinical Practice (GCP)
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings, and create action plans by generating regular visit reports, follow-up letters and other required study documentation
  • Support the development of study subject recruitment plan for each clinical site, and work with sites to adapt, drive and track the plan in line with project needs
  • Monitor the completeness and quality of regulatory documentation, and perform site document verification
  • Establish regular lines of communication with sites to manage ongoing project expectations and issues
  • Review the Electronic Data Capture (EDC) platform for completeness and accuracy, and conduct data query generation and resolution
  • Manage the progress of assigned studies by tracking regulatory submissions, approvals, recruitment, and enrollment
  • Escalate quality issues as appropriate
  • Collaborate and liaise with study team members for project execution support as appropriate
  • Perform central monitoring

Experience and Skills you’ll bring to the role

  • Bachelor’s Degree in Life Sciences or equivalent experience with a Nursing background
  • Minimum of 2-3 years of independent on-site clinical monitoring experience
  • Oncology experience and working on phase 1 trials strongly preferred
  • Thorough and in-depth Good Clinical Practice (GCP) knowledge
  • Advanced site monitoring and management skills
  • Strong attention to detail, organization, and problem-solving abilities
  • Valid Driver’s License

The following experiences or abilities are assets

  • Previous experience as an Oncology nurse is an asset

Working conditions 

  • Works remotely and will need to work flexible work hours
  • Works with minimal supervision
  • Travel, including air travel, is required and is an essential function of the job
  • 50 – 70% business travel required

Join the Virogin team to learn, grow, make a difference, and have fun in the process! For more information about our company, visit www.virogin.com.

COVID-19 vaccination is an employment requirement; accommodations will be considered upon request.

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