Clinical Research Associate Job at BioSpace, Inc., San Jose, CA

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  • BioSpace, Inc.
  • San Jose, CA

Job Description

Job Details

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
  • Fluency in Mandarin is preferred. We welcome applicants from diverse linguistic backgrounds
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
BioSpace, Inc.

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