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Job Details

Freelance Monitor/CRA 20%

Company: CTC Resourcing Solutions
Location: Bern, Switzerland
Reference: 895145-P
Closing Date: 03 Dec 16
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

To monitor a centre in Bern, Switzerland of a Regional Clinical Trial in accordance with the protocol, ICH GCP guidelines, applicable local and international regulations and company SOPs to support the regulatory approval and commercialization of the product.

Requirements:

Reference Number:        895145-P

Type of placement:        12-24+ months

Workload:                       20% (3-4 days a month)

Location:                        Bern, Switzerland

 

Purpose:

To monitor a centre in Bern, Switzerland of a Regional Clinical Trial in accordance with the protocol, ICH GCP guidelines, applicable local and international regulations and company SOPs to support the regulatory approval and commercialization of the product. 

 

Main Responsibilities:

  • Have a clear understanding of the company’s standard operating procedures (SOPs), of the study protocol and of the Case Report Forms (CRFs) in order to be compliant with the procedures
  • Prepare relevant study documents i.e. patient information, informed consent form, labels for study drugs etc. (including translations)  for EC submissions and Swissmedic notification
  • Conduct the study including: start-up visit,  briefing (training) of investigators and other personnel at the site participating in the trial; monitoring the study including source data verification at agreed intervals according to SOP’s and company monitoring plan. Close down visit ensuring that the trial file is completed and that the investigator is aware of obligations on retention of trial documents and that unused documents and drug supplies are removed for disposal
  • Maintain professional relationship with the investigators and assure that the investigator is adhering to the protocol and GCP
  • Provide training for staff at the site where appropriate
  • Assessing and timely reporting of SAEs to headquarter and local authorities (Swissmedic)
  • Ensure appropriate monitoring of clinical trial material orders and stock and provide timely feedback to Study Teams and local Study Drug Co-ordinator on changes in drug supplies i.e. orders for extra material
  • Work closely with the international clinical study teams/CRAs and HCR to ensure transmission of trial data and any relevant information
  • Supervising of the trial budget and regular payment of patient fees to the investigators
  • Participation in investigator’s meetings, study meetings and trainings organized by Headquarters.
  • Control the local clinical trials in terms of patient recruitment, quality of data, clinical supplies and budget

 

Qualifications and Experience:

  • Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline
  • At least 3 years experience as CRA/monitor with experience of working in Switzerland
  • Excellent working knowledge of ICH GCP guidelines and local guidelines
  • Fluent in both German and English
  • Good command of French is an asset
  • Communication and project management skills
  • Business orientated and flexible
  • Willing to travel as required for the position

 

Apply for this job: Freelance Monitor/CRA 20%

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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