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Clinical Trials Documentation Specialist

1 month ago

Englewood, Colorado, United States LabCorp Full time
Job Summary

We are seeking a highly skilled Clinical Trials Documentation Specialist to join our team at LabCorp. As a key member of our Clinical Trials team, you will be responsible for providing support in the secondary review of core and clinical trials project-related assay documentation and raw data for accuracy, completeness, and compliance with internal processes and procedures.

Key Responsibilities:

  • Review checklists for clinical trials data generated by technical staff for accuracy and completion of documentation, including review of supportive documentation as needed to ensure compliance with internal processes.
  • Provide review of QC change documentation generated by the QC lead.
  • Review data generated in study-specific templates or spreadsheets used by technical staff to include check of manual calculations if applicable.
  • Assist in study test set up in laboratory information system test code submission, sample requirements, and/or review of data elements for submission.
  • Review study documentation binders to ensure proper documentation is in place during feasibility, validation, and phase I-III studies (checklists, etc).
  • Notify management of discrepant data or deviations observed in data review for clinical trials documents and assist with investigation and assigning root cause for deviations from internal procedures.
  • Communicate with laboratory technical staff to ensure data review findings are concurrent with established SOPs and proper documentation procedures.
  • Document all activities as necessary, including preventative maintenance logs, instrument function checks, troubleshooting, and quality control to ensure regulatory compliance.

Requirements:

  • Bachelor's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology, or meet local regulatory (CLIA & State) requirements.
  • Previous clinical laboratory testing experience is not required.
  • ASCP or AMT certification is preferred.
  • Ability to work independently and within a team environment.
  • Proficient with computers; familiarity with laboratory information systems is a plus.
  • High level of attention to detail along with strong communication and organizational skills.
  • Must be able to pass a standardized color vision screen.
  • Flexibility to work overtime or other shifts depending on business needs.
  • Relevant QA/QC experience in pharmaceutical/biotech/laboratory industry or working knowledge of GxPs or FDA regulations highly preferred.

LabCorp is an Equal Opportunity Employer:

We are committed to diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.