Clinical Research Associates

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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