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Clinical Research Associate

2 months ago

San Jose, California, United States KlinEra Global Services Inc Full time

Qualifications

  • Bachelor's degree in life science/related field, advanced degree preferred
  • Minimum of 3+ years in clinical research industry
  • Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to manage multiple priorities and work effectively in a team environment

    Responsibilities
    • Participate in study protocol review and development
    • Assist in site selection and qualification process
    • Develop study documents such as informed consent forms (ICFs) and study manuals
    • Conduct site initiation visits (SIVs) to train site staff on study protocols and procedures
    • Verify site capabilities and ensure availability of necessary study materials
    • Assist with regulatory document collection and submission
    • Perform routine monitoring visits to clinical sites according to the monitoring plan
    • Ensure adherence to the protocol, GCP, and applicable regulatory requirements
    • Review and verify data accuracy and completeness in source documents and case report forms (CRFs)
    • Track subject recruitment and enrollment status at clinical sites
    • Ensure timely resolution of data queries and discrepancies
    • Monitor investigational product (IP) accountability and storage conditions
    • Review safety data and ensure proper documentation and reporting
    • Conduct close-out visits to ensure completeness of study documentation and data
    • Assist in the resolution of outstanding issues and data queries
    • Ensure proper archiving of study documents and materials
    • Maintain regular communication with study sites, investigators, and sponsors
    • Provide study progress updates and reports to project teams and stakeholders