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Physician / California / Locum or Permanent / CRA / CTM Job

Company: Tandym Health
Location: Irvine
Posted on: September 18, 2022

Job Description:

A medical technology company in California is currently seeking a new CRA / CTM. In this role, the CRA / CTM will be responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative.

Responsibilities
The CRA / CTM will:


  • Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision
  • Prepare and document study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects
  • Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used
  • Conduct site monitoring (qualification, initiation, periodic monitoring and close out visits) to ensure and document site is trained to follow study procedures per protocol
  • Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations
  • Ensure accountability of Investigational Devices and study supplies are performed, when appropriate to the study
  • Ensure complete reporting and proper documentation of monitoring activities
  • Ensure sites are identifying issues and implementing corrective and preventative actions to ensure inspection readiness
  • Suggest improvements to departmental procedures relating to GCP monitoring aspects
  • Ensure essential study documents are accurate, complete, and properly organized and stored as quality records
  • Conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables
  • Write clear, succinct and detailed clinical study and technical summary reports
  • Perform special projects, as requested


    Qualifications


    • Bachelor's Degree
    • Experienced with Good Clinical Practice (GCP) in conduct of clinical studies;
    • Microsoft Office Suite proficient
    • Solid analytical and research skills
    • Great interpersonal skills
    • Excellent communication skills (written and verbal)
    • Strong attention to detail
    • Highly organized


      Desired Skills:


      • Bachelors Degree in Science or in a related field
      • CRA certification training
      • Experience with medical devices;
      • Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology)
      • Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements

Keywords: Tandym Health, Irvine , Physician / California / Locum or Permanent / CRA / CTM Job, Healthcare , Irvine, California

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