Clinical Research Associate (CRA) | Home-based or office-based at our Italian branches

Job Locations | Austria, Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Norway, Poland, Portugal, Spain, Sweden, Switzerland, The Netherlands.

Responsibilities
CVBF is searching for experienced Clinical Research Associates to conduct oversight and monitoring activities for no-profit paediatric clinical trials. The expected starting date for this role is March 2020.

The successful candidate will be working on one / two non-commercial studies.

We are looking for confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the Clinical Operations team and the clinical sites’ staff. Working as an integral part of the CVBF monitoring-service study team, which he/she will constantly interact with, both remotely and with occasional meetings, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle.

Key responsibilities include:

• Planning and conducting various site visits (site qualification and initiation, monitoring at sites and remote, close-out) in accordance with the clinical monitoring plan.
• Developing effective collaboration with investigator site staff to ensure that key clinical metrics are met.
• Ensuring the proper storage and accountability of clinical supplies and following-up of drug safety issues.
• Ensuring integrity of clinical data by sufficiently maintaining site tracking records and working in compliance with relevant guidelines.

Qualifications

To enable success in this position you will have:

• University degree in a science related field or certified health care professional or equivalent experience
• At least 5 years of prior experience conducting monitoring visits, including site management, from either a pharmaceutical company or a CRO/SMO environment.
• An in-depth working knowledge of ICH-GCP guidelines and local and international regulatory requirements.
• Fluency in English and local language (spoken and written).

How to apply

Interested candidates are invited to send their updated CV, together with the completed CRA assessment form and a cover letter, specifying the job offer reference, the current position, salary, and notice period to [email protected].