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