Perm In-House Clinical Research Associate I

Category: CRA
Job #: 10673
Location: Lake County OH or Orange County CA
Job Type: Perm
Rate / Salary Range: Competitive Salary

One of our Sponsor partners is looking for a data driven Clinical Research Professional to become part of their close knit team. The ideal candidate is seeking a long-term growth opportunity with a collaborative, outstandingly dynamic team, working on an amazing product!

Job Responsibilities:
  • Assist in study start up activities including collection and tracking of essential documentation needed for site initiation
  • Ensures compliance with Sponsor SOPs, Study Protocol, GDP, GCP and Regulatory
    Conduct periodic assessments of documents submitted to the eTMF and manage an assessment tracking tool throughout a study’s lifecycle.
  • Maintain awareness of study events and associated documentation requirements through collaboration with functional/sub-functional area study team members.
  • Effectively manage clinical study sites by building strong and collaborative relationships with Investigators and staff.
  • Responsible for regularly reviewing site recruitment, ensuring timely implementation of contingency plans to ensure recruitment goals are met.
  • Generate and assist in the closure of data queries and follow-up on safety issues and safety reports in a timely manner.
  • Proactively identify, document, and assist in the resolution of issues relating to subject recruitment, study data quality, and study conduct at assigned study sites.
  • Provide status of site activity via regular presentation to management
Job Qualifications:
  • This is an in-house position, so must live locally in the Lake County Ohio or Orange County California areas
  • Being technologically savvy is required
  • Must possess excellent communication skills
  • Bachelor's Degree Required

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