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Senior Clinical Research Associate

United BioSource Corporation (UBC)


Location:
Kansas City, Kansas
Date:
05/10/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
United BioSource Corporation (UBC)
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Job Details

United BioSource Corporation (UBC), an Express Script’s company is the leading provider of integrated development and commercial support solutions that deliver evidence of safe use while optimizing access to mediation and care. We are seeking a Senior Clinical Research Associate to join our team.

Brief Description:

Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project Standard Operating Procedures (SOP)s

Essential Functions:

  • Monitors clinical trials to ensure investigator and sponsor responsibilities are compliant with regulatory requirements
  • Thorough knowledge and application of project specific protocol
  • Consistently completes on site monitoring in accordance with project specific timelines
  • Consistently completes travel scheduling in accordance with project specific and UBC guidelines
  • Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings
  • Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
  • Ensures follow-up of site issues and action items per UBC/sponsor timelines
  • Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
  • Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
  • Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
  • Completes Regulatory Binder and Investigational Product reconciliation
  • Maintains regular contact with assigned sites per study requirements
  • Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines
  • Consistently completes SOP review and documentation within requested timelines
  • Consistently completes sponsor specific training and documentation within requested timelines
  • Assists PM and management team by being an AIM leader
  • Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
  • Instruct how to conduct visit, report/letter writing and manage issues and actions
  • Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
  • Assists management team by mentoring other CRAs
  • Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training

Qualifications:

  • Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience
  • Minimum of > 24 months active monitoring
  • Thorough knowledge of medical terminology
  • Good written and verbal communication skills
  • Consistently meets or exceeds metrics for quality trip reports and letters
  • Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation
  • Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable)
  • Thorough knowledge of ICH, GCP, CFR and UBC SOPs
  • Up to 80% travel

Job Type: Full-time