Job Title: CRA
Contract Type: Permanent
Location: Italy,
Salary: Negotiable
Start Date: 21/11/16
Reference: 67852-PHARM-FRC
Contact Name: Fareen Choudhry
Contact Email:
Job Published: November 04, 2016 18:13

Job Description

Clinical Research Associate

Clinical Research Associate's required for a leading CRO to join their expanding team of experienced CRAs. You will be home based in either Rome or Milan.

Key responsibilities:

·You will identify, select, initiate and close-out appropriate investigational sites for clinical studies. You will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP.
·You will ensure the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
·Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
·Assist with study protocol design, development and / or review if required
·Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
·Provide support to the Project Manager / Country Manager with ad-hoc tasks as required

Candidates Criteria:
·Bachelor's degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
·Minimum 18 months' experience of independent monitoring
·Clear understanding of the drug development process
·Significant experience in performing a Clinical Research Associate role
·Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
·Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
·Ability to contribute to the development of clinical trial related documents and materials
·Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
·Fluency in English and Italian (both written and spoken)
·Oncology experience preferably
·Willingness and ability to travel
·Willingness and ability to be Home based in Rome or Milan

Get in touch with Fareen Choudhry for more information: / 01737 236 737

CRA / CRA II / Clinical Research Associate / Life Sciences / Oncology / Italy / Europe / Milan / Rome / Clinical trials / CRO / Clinical Research Organisation

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