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Job Details

Clinical Research Associate Germany

Company: CROMSOURCE
Location: Germany
Reference: HQ00001010
Closing Date: 17 Nov 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

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Job Summary:

Job Title: Clinical Research Associate II/III   Location: Germany Schedule: Full time, permanent, Home based   Main Job Tasks and  Responsibilities Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance Conducts and reports...

Requirements:

Job Title: Clinical Research Associate II/III

Location: Germany

Schedule: Full time, permanent, Home based

Main Job Tasks and Responsibilities

  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Adapts and translates Patient Information Leaflets and Informed Consent Forms
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
  • Escalates any issues to relevant project team members
  • May assist in contract negotiation with sites on study budget after appropriate and documented training
  • May support the submission process in the project (or region)

Education and Experience

  • You have a University Degree in scientific medical or paramedical discipline
  • Prior experience as a CRA
  • Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook
  • Willingness to travel

CROMSOURCE offers

As a Netherlands employee you will be entitled to the following benefits in addition to your competitive salary:

  • 25 days annual leave, plus bank/public holidays
  • Opportunity to partake in the pensions scheme
  • Car allowance
  • Development opportunities

If you would like to be considered for this exciting opportunity pleased send your CV directly to myna.yeboah@cromsource.com

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Germany

Clinical Research Associate

Apply for this job: Clinical Research Associate Germany

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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