Sr Clinical Research Associate - France

Job Title: YLM02H - Senior Clinical Research Associate (SCRA)

Our CRAs / Sr CRAs Monitor in accordance with International Conference on Harmonisaton, Good Clinical Practice guidelines, Code of Federal Regulations and UBC and project SOPs.
 

Specific job duties: 

• 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 Clinical Site Specialist/Regulatory Document Specialist 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 UBC’s Clinical Trial Management System.
• Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol.
• Monitors within Electronic Data Capture data entry, if applicable, and assists sites with Case Report Form 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 Assess Instruct and Mentor leader
  1. A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently.
  2. I = Instruct how to conduct visit, report/letter writing and manage issues and actions.
  3. M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit.
• Assists management team by mentoring other Clinical Research Associates.
• Assists with preparation and/or delivery of presentations for UBC Clinical Research Associate training, departmental training and/or sponsor specific training.

Supervisory Responsibility: N/A

Desired Skills and 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 UBC’s Clinical Trial Management System, Electronic Data Capture System, Outlook and client specific systems (if applicable)
• Thorough knowledge of International Conference on Harmonisaton, Good Clinical Practice guidelines, Code of Federal Regulations and UBC SOPs

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