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Job Details

Clinical Research Associate II or III

Company: CROMSOURCE
Location: Home Based - UK
Reference: CRO/VW/HQ00000442
Closing Date: 10 May 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Currently CROMSOURCE is looking for an experienced CRA II or III to join our internal division, to work on an array of exciting drug and medical device studies. This is not just a routine monitoring position, but rather it will also involve start up activities such as contract negotiation and finalisation, and submissions.

Requirements:

Main Job Tasks and Responsibilities

  • Monitors clinical studies and assures high quality of the clinical data
  • 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
  • May act as Feasibility Associate 
  • Performs training of site staff in all study procedures in order to ensure protocol/ICH-GCP 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) 
  • Conducts source data verification and in house review of clinical data and ensuring timely resolution of data queries to guarantee reliable clinical data
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reactions such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project
  • Is the main contact person for the site in order to ensure close follow up
  • Promptly addresses the Projects Coordinators/Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned
  • 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), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. 

 

 Education and Experience

  • University Degree in scientific, medical or paramedical disciplines
  • Previous experience as a CRA 
  • Good Knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

 

Benefits we offer:

  • Car allowance
  • 25 days annual leave plus 8 bank holidays
  • Pension (5% of salary)
  • Group life assurance (up to 4 times annual salary)
  • Eye care
  • Childcare vouchers
  • Home based employees get internet reimbursement of up to £30 per month

 

Cromsource is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients without standing 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.   

Apply for this job: Clinical Research Associate II or III

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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