Clinical Operations Specialist

The Clinical Operations Specialist provides raw data review, image processing and site communication support to the Clinical Operations Associate for assigned studies.

Responsibilities:

• Review, Track and monitor all image data recieved from clinical sites
  • Perform Data Entry 2
  • Load and label of digital images
  • Loading of image analysis results into DXAsure
• Assist in them moitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management.
• Investigate and complete logistical edit checks.
• Assist in preparation and reproduction of study materials during study startup phase of clinical trial.
• Generate site and patient reports, and verify reports prior to distribution to clinical sites
• Assist clinical operations associate with providing technical site support (i.e. field clinical site questions pertaining to image data, confirm site eligibility)
• Generate queries (i.e. data clarifications, incomplete package notifications, repeat request notifications) for resolution with clinical sites
• Schedule logistical and technical trainings with clinical site personnel
• Create test run requests for clinical sites submitting digital data
• Report issues found with study systems (i.e. study database, reading analysis system) using bug/issue track system
• Assist with training Operations Assistants on assigned studies
• Preparation and review of materials for internal and external audits or monitoring visits

Qualifications:

Education:

• College Graduate. Science background preferred.

Experience:

• Knowledge of "good clinical practices" preferred.

Skills:

• Able to function effectively in a changing and dynamic environment
• Familiarity with PC-based computers and standard software packages including e-mail, word processors, spreadsheets and databases.
• Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines. Strong attention to detail and organizational skills. Strong written and verbal communication.
• Knowledge of basic clinical research preferred. Knowledge of anatomy a plus