Sr Clinical Research Associate - France

Hiring By - Biostaffic

 BioPharma

France

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
We are currently recruiting for CRA / Sr CRA to join our Clinical Team in France.
UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.
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
  • A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently.
  • I = Instruct how to conduct visit, report/letter writing and manage issues and actions.
  • 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
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
UBC
UBC

Current Openings: 0

United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and ultimately, drive better patient outcomes.
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