ALLEN SPOLDEN
ALLEN SPOLDEN
ALLEN SPOLDEN фармацевтика, биотехнология, денсаулық сақтау және қоғамдық денсаулық сақтау ұйымдарына клиникалық зерттеулерді жүзеге асыратын және қолдайтын командаларды құруға әрі қолдауға көмектеседі. Компанияның жұмыс күші мен зерттеу шешімдеріне функционалдық қызмет көрсетуші қолдауы, клиникалық деректерді басқару, реттеуші мәселелер бойынша кеңес беру және жоба қажеттіліктеріне бейімделген мамандандырылған кадрлармен қамтамасыз ету кіреді. Салалық сараптаманы операциялық қолдаумен ұштастыра отырып, компания клиникалық зерттеу командаларына тиімдірек жұмыс істеуге, сондай-ақ зерттеу операцияларындағы өнімділік пен талаптарға сәйкестікті сақтауға көмектеседі.

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.

Сипаттама

  • 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

Талаптар

  • 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

Артықшылықтар

  • 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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