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Job Details


Company: Docs Global (Continental Europe)
Location: Slough,Italy
Reference: Ref AS-004016
Closing Date: 28 May 17
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

Interesting opportunity as CRA II/III Home Based to join an international company working on independent way.


Roles & Responsibilities of the position

- Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
- Performs pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP
- Performs initiation visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP
- Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability
- Communicates effectively with site personnel, including the Principal Investigator (PI), and management to relay protocol/study deviations and ensure timely implementation of corrective actions
- Develops and maintains strong working relationship with Investigators and study staff
- Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion
- Liaises with data management to resolve data discrepancies and ensure all data management study goals are met
- Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP
- Prepares accurate and timely visit reports from all types of visits

Job Requirements

- Previous experience within a CRO or Pharma environment
- A degree in a Science discipline is required
- Certification as a CRA under the Italian Decree
- Experience in the management of EC submission and site contract negotiation
- Site set-up and monitoring experience at least of 2 years
- Experience of Oncology is required

-The ability to write and speak fluent English is essential
- Ability to drive and availability for domestic and international travel including overnight stay
- Demonstrated ability to work independently

Remuneration & other details

Home based Position -Permanent Contract

Apply for this job: CRA III

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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