ALLEN SPOLDEN
ALLEN SPOLDEN
ALLEN SPOLDEN helps pharmaceutical, biotech, healthcare, and public health organizations build and support the teams behind clinical research. Its workforce and research solutions include functional service provider support, clinical data management, regulatory affairs guidance, and specialized staffing tailored to project needs. By combining sector expertise with operational support, the company helps clinical trial teams work more efficiently while maintaining productivity and compliance across research operations.

Clinical Data Reviewer - Remote in the United States

Review clinical and laboratory data for a global clinical research organization. Investigate discrepancies, issue site queries, and help maintain audit-ready trial records.

Description

  • Evaluate clinical and laboratory data for accuracy, consistency, and completeness
  • Investigate discrepancies that require clarification from study sites
  • Use clinical, laboratory, or patient-care knowledge to detect implausible or inconsistent information
  • Prepare and send site data queries using approved guidelines and templates
  • Compare laboratory results with concomitant medications, adverse events, and medical history
  • Review medical coding under the direction of senior reviewers
  • Identify data quality patterns, protocol compliance concerns, and training requirements
  • Maintain audit readiness by following SOPs and keeping documentation accurate
  • Take part in Protocol Deviation, Data Review and Quality Team (DRQT), and Safety Monitoring Team (SMT) meetings
  • Prepare listings, trackers, and presentation slides for data review meetings

Requirements

  • Associate-level or bachelor's education, or a relevant diploma or certificate combined with practical experience, in life sciences, laboratory science, or an allied health discipline
  • Up to two years of experience in a clinical, laboratory, dental, or healthcare environment, including internships, clinical placements, or externships
  • Ability to read and interpret patient information such as vital signs, laboratory values, medication and allergy lists, treatment or procedure notes, and charts
  • Working knowledge of medical terminology and precise documentation practices
  • Strong written and verbal English communication skills with careful attention to detail
  • Well organized, with the ability to manage several tasks and meet deadlines
  • Proficiency with Microsoft Excel and other Microsoft Office tools
  • Relevant certification or licensure is preferred
  • Experience using EHR/EMR, practice management, or LIMS systems is preferred
  • Interest in oncology or another clinical specialty is preferred

Benefits

  • Training in clinical trial processes, clinical database navigation, query development, and medical coding
  • Mentorship to support skill and confidence development
  • Remote work arrangement

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