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Job Details

Clinical Research Associate

Company: Chiltern
Location: Bulgaria
Reference: SKBULG
Closing Date: 19 Sep 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

• Clinical Research Associate • Office Based Bulgaria • Working for Chiltern

Requirements:

Job Background

Due to our continuing success and expansion, Chiltern are currently looking for experienced Clinical Research Associates to work with our team in Bulgaria.
 
CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The work will involve Clinical Monitoring activities for designated projects and to monitor specified sites to ensure quality and integrity of data, compliance with Chiltern International or Sponsor’s SOPs, ICH GCP, and regulatory requirements, ensuring study completion on time and within budget

Job Primary Functions:

  • The successful applicant will be responsible for coordinating Phase I-IV clinical trials in Europe
  • Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.
  • Assist with document submissions to local authorities
  • To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
  • Ensure that all study related communication including e-mail is tracked, printed and filed as required
  • To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
  • To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study
  • To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
  • Other Ad-Hoc CRA duties

Job Qualifications:

  • A BSc or BA degree in a biomedical or related life science, or nursing qualification
  • Candidates should ideally have 1 year + CRA experience
  • Good clinical knowledge with an understanding of medical terminology
  • An understanding of the basics of physiology and pharmacology
  • Understanding of the principles of ICH GCP and regulatory requirements
  • Experience using a clinical trial management system
  • Preferable experience using a clinical trial management system (CPMS)
  • Experience as a CRA on single site and/or multicentre trials
  • Good oral and written communication, organizational skills and personal presentation
  • The ability to communicate effectively in Bulgarian and English language.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

Therapeutic Focus
The successful candidate will have well rounded and recent therapeutic experience within the areas of Biopharma (mixed therapeutics)

 

Additional Information:

  • This is a permanent, full time role
  • Work will be required away from Chiltern offices, at Sponsor offices, and will require national travel
  • May also involve travel to meetings or attendance at conferences
  • Overnight stays may be required
  • No freelance applications

 

To apply for this position please send your CV to Sergei.Kozhin@covance.com - Sergei.Kozhin@covance.com or for a confidential discussion please call Sergei on +7 495 775 7310.

 

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response

 



Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

Competitive salary and benefits

Position Type

Permanent
Full Time

Contact

Email Nicky Cooke - Nicky.Cooke@chiltern.com
+44 (0) 1753 216729

Apply for this job: Clinical Research Associate

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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