Proclinical Staffing

Clinical Research Associates

Location
Milan (province), Milano, Italy
Salary
Negotiable
Posted
22 Jan 2021
Closes
05 Feb 2021
Ref
35186
Contact
Maria Salvador
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Proclinical has partnered with a global Contract Research Organisation in search for Clinical Research Associates. The role will be in Italy, and is an opportunity to propel your clinical career.

Job Responsibilities

  • Collect the feasibility questionnaire (if applicable) and other documents necessary for the ethical and administrative submission
  • Check the willingness of the Investigator to cooperate so the study can take place according to the protocol guidelines and in compliance with ICH-GCP and legislation/regulations
  • Verify that the Site is suitable with regard to its structure, instruments and the availability of patients affected by the pathology being studied
  • Ensure that the Investigator and staff have adequate training and act according to protocol
  • Train the Site staff according to the foreseen procedures and work instructions
  • Update/check the Investigator's Folder and the Trial Master File (paper and/or electronic, as applicable) according to OPIS and/or Sponsor procedures
  • Handle study materials, including study drug(s), as foreseen for the specific study and as applicable
  • Gather all information about patients prematurely terminating the study
  • Check the expiration date of the investigational drug and act promptly to return drug to the Sponsor before it expires
  • Manage queries on an ongoing basis and within the timeframes set
  • Promptly manage and follow-up protocol deviations, interacting with the Clinical Team and the Site staff
  • Write up reports after each visit and each significant contact with the Investigator/Site staff within the timeframe required
  • Write up and sent follow-up communication to the Site staff according to the procedures and timeframes applicable for the study
  • Gather CRF corrections (signed and dated) when necessary and when applicable

Skills and Requirements

  • B.A./B.S. preferred with strong emphasis in science
  • Min. 2 years of direct site monitoring experience in a pharma/CRO.
  • Monitoring experience min 2 years

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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