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Senior Clinical Research Associate

Location: San Diego, California Salary: competitive
Sector: Clinical Research Type: Contract

Our client is looking for a Clinical Research Associate to join an energetic company for a one year contract. The main focus of the role will be to support the early phase group by carrying out and conducting monitoring visits.

Responsibilities include:

  • Conduct visits to clinical study sites from qualification and initiation to closeout
  • Monitor the studies to ensure quality and accuracy of data against source documents
  • Responsible for monitoring studies against defined milestones and timelines to assure that all deliverables are met as described in the Monitoring Plan
  • Maintain eTMF for all clinical sites and perform eTMF reconciliation
  • Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks
  • Assist in improving and maintaining SOPs
  • Able to help the site navigate informed consent issues and support IRB approval process

Requirements:

  • Bachelor's degree preferred
  • Ability to travel up to 50%
  • At least 5 years of previous monitoring experience preferred
  • Knowledge and understanding of clinical research regulatory requirements i.e. GCP and ICH guidelines
  • Proven written and verbal skills
  • Demonstrated ability to go above and beyond what is asked of them

Sthree US is acting as an Employment Business in relation to this vacancy.