Curebase is seeking a Clinical Quality Associate who will thrive in a quickly scaling healthcare technology environment. This role will be responsible for conducting risk-based quality management (RBQM) surveillance of Clinical Operations activities, with an emphasis on risks impacting patients’ safety and data quality, to ensure compliance with internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR) related to clinical quality. This role reports directly to the Director of Clinical Quality.

What you’ll do

  • Conduct quality reviews of clinical trial data and documentation (e.g., essential documents [i.e., TMF, ISF], clinical database, training records)
  • Manage non-compliance (e.g., regulatory, protocol, SOP) and clinical quality issues, ensuring appropriate actions and documentation (e.g., incident reports, CAPAs)
  • Review of clinical trial data and documents (e.g., protocol, consent) for quality and regulatory compliance
  • In collaboration with Clinical Operations, ensure trials are inspection ready at all times
  • Assist with initial and recurring risk identification, assessment, and mitigation activities
  • Participate in activities related to client audits and regulatory inspections
  • Participate in the evaluation and qualification of external partners (e.g., clinical sites, vendors), including conducting audits (remote or in-person) on an as needed basis
  • Contribute to the oversight and maintenance of controlled documents related to clinical quality assurance within the Quality Management System
  • Assist in tracking and assessment of clinical quality compliance metrics to identify risks and trends across clinical trials
  • Collaborate with Clinical Operations in the development of study-level plans related to quality management (e.g., Clinical Monitoring Plan)
  • Implement study-specific Quality Management Plans, as applicable
  • Participate in the implementation of clinical quality improvement initiatives

About you

  • Bachelor’s degree in life sciences or related field
  • Minimum of three years’ experience in clinical research
  • Well-versed in relevant ICH-GCP, US CFR, and HIPAA regulations
  • Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
  • Proven ability to work well with a remote-based team
  • Ability to excel in a fast-paced and rapidly changing environment
  • Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
  • Willingness to travel for job-related activities if required (expected travel for this position is < 10%)

About Curebase

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