Clinical Research Associate .
Milan - Italy
Depending on experience
*URGENT HIRING NEED * TRAVEL ESSENTIAL * RAPIDLY GROWING CRO*
Due to a record growth year, the company is expanding in all areas and we’re looking for multiple CRAs at various levels to support the number of incoming studies. The company is based in Italy, so they are looking for people based in this area, with a willingness to travel. The company offer extremely competitive salaries and benefits.
- Maintain patient and Sponsor confidentiality, check Investigator willingness, collect feasibility questionnaire, collect documents for ethical and administrative purposes, ensure essential documents are correctly signed and managed.
- Perform site monitoring activities: pre-study/selection visits, qualification and resource/facilities visits, site suitability visits, initiation, monitoring visits and close-out visits.
- Ensure that the Investigator and staff have adequate training including the Investigational Medicinal Product and the ICH-GCP.
- Ensure materials and drugs have arrived at the site in due time. Handle the materials, including study drugs and ensure residue materials are collected and returned to the Sponsor.
- Contact Sites to check patient status, resolve queries and manage various issues.
- Ensure accuracy and completeness of data entered into electronic systems and ensure that patient confidentiality is respected.
- Verify that serious adverse events have been reported using SAE form.
- Promptly manage and follow-up protocol deviations, interacting with the Clinical Team and Site staff.
- Collect CRF pages according to the study procedures.
- Maintain all files and documentation pertaining to studies.
- Report writing of each visit and each significant contact with the Investigator/Site staff.
- Facilitate colleague training: clinical, regulatory, administrative and company procedures and processes.
- Degree within a scientific field.
- In depth knowledge of GCP and techniques for the monitoring of clinical trials.
- Obtain requirements of Ministerial Decree 15.11.2011 in order to conduct interventional clinical trials
- 2 years + experience in managing and conducting clinical trials.
- Good knowledge of the English language.
- Good knowledge of Office Suite.
- Able to work independently under the supervision of the Project Managers, Clinical Research Line Managers and Head of Clinical Operations Unit.
- Able to interact with the personnel of clinical trials.
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