Permanent Clinical Research Associate in Milan, Italy
Prime Pharma is looking for a Clinical Research Associates (CRA) for a new permanent CRA job that has arisen in Milan, Italy due to increasing workloads within research projects.
For this job you will preferably have experience in Central Nervous System (CNS) and / or Gastro Intestinal (GI) trials. The successful candidate will have a minimum of 12 months prior experience of working as a clinical research associate in a Clinical Research Organisation, Biotech or Pharmaceutical company. And will be office based in Milan
RESPONSIBILITIES
The successful candidate will undertake routine monitoring on behalf of our client.
- Develop and write trial protocols and present to steering committees
- Design case record forms (CRFs)
- Manage ethics committee and regulatory authority applications
- Locate and assess suitability of facilities at a study centre
- Liaise with clinical staff and Principle Investigators (PIs) on conducting the trial
- Set up the study centres
- Train site staff to industry standards and SOPs
- Monitor the trial throughout its duration, which will involve visiting the study centres on a regular basis. You will travel approx 60% of the time and this will include some overnight visits;
- Confirm source data/document verification (SDV)
- Collect completed CRFs
- Write, file and collate trial documentation and reports
- Ensure all unused trial supplies are accounted for
- Close down study centres on completion of the trial
- Discuss results with a medical statistician
- Archive study documentation and correspondence
- Prepare final reports and occasionally manuscripts for publication
SKILLS AND QUALIFICATIONS
- Excellent English and Italian language skills (written, spoken and reading)
- Strong organisational skills and time management skills
- Excellent interpersonal skills both written and verbal
- Ability to confidently communicate with an array of internal and external contacts
- Excellent attention to detail
- Willingness to undertake nationwide travel for monitoring purposes
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
- Thorough knowledge of ICH-GCP guidelines, the EU Clinical Trials Directive and all UK ethical and regulatory procedures
- A Life Sciences Degree
For more information about this opportunity, please contact Adrian Barnard on 020 7318 5261 or email abarnard@primepharmapeople.com
