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Job Details

Senior Clinical Reasearch Associate (Netherlands)

Company: United BioSource Corporation.
Location: Netherlands (Home-Based)
Reference: "."
Closing Date: 27 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

We are currently looking for an experienced Clinical Research Associate (CRA) to join us on a permanent, full-time, home-based role in the Netherlands.

Requirements:

We are currently looking for an experienced Clinical Research Associate (CRA) to join us on a permanent, full-time,  home-based role in the Netherlands.

Job Description

Monitors in accordance with Good Clinical Practice guidelines, UBC and project SOPs.

Essential Functions

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 timeline

Assists PM and management team by being an Assess Instruct and Mentor leader

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
 

Requirements

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  

Apply for this job: Senior Clinical Reasearch Associate (Netherlands)

Contact Information:

Address:  Corporate Headquarters
Blue Bell, Pennsylvania, 920 Harvest Drive, Suite 200 Blue Bell,
PA 19422
USA
Tel:  +1.215.591.2880
Website:  Visit Our Web Site

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