Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Clinical Research Associate (Regional Site Manager) - SCRA

Company: Chiltern
Location: UK Flexible Location
Reference: MLJALL10
Closing Date: 04 Jan 19
Type: Full Time
Salary (£): On Application
Benefits: Flexible Benefots inc Car/Allowance, 25 days leave, pension, LI, gym subscription membership

Job Summary:

Chiltern, a Covance company are currently in a strategic partnership with a global healthcare company based in Marlow in the UK. We provide the “monitoring function” to this company which in effect means that we provide a team of CRAs across the Western EU region on rolling 12 months contracts. We are now looking to add a SCRAs to the team, starting January/February 2019.

Requirements:

This is a full time role.

Home Based.

Dedicated 100% to one Client.

Risk Based/Remote Monitoring -  UK wide site coverage.

Less Travel!

You would be employed by Chiltern, a Covance company on a permanent basis - PAYE salary and full and comprehensive benefits. You would be seconded to our Client and oversee monitoring activities in the UK and Ireland.

The CRA in this model is called a Regional Site Manager (SCRA level)

In terms of location, we are flexible as long as UK based.

Current studies are in Gastointestinal and Botox (overactive bladder) - you would be involved initially in site identification AND site initiation onwards.

PLEASE NOTE - it is ESSENTIAL that you have a pharma or CRO monitoring background.

Tasks and Responsibilities of the Regional Site Manager


• Study start up; regulatory/ethics site support site feasibility
• Site qualification visits (SQVs) and site selection
• Site set-up (including initiation visits)
• On-site monitoring
• Remote monitoring
• Site management (contact between on-site visits)
• Site close-out

The Regional Site Manager role deliverables include, but are not limited to, the following:

 

• Site-level feasibility Protocol Specific Monitoring Plan execution and compliance
• Clinical site visit reports within metric timelines
• Site specific patient recruitment and retention plans (shared deliverable)
• Ensure collection of high-quality clinical trial data (CRFs)
• Query, Action Item and Issues timeously resolution
• Attend site audits and inspections, including corrective and preventative action responses to monitoring-related observations of audits and inspections
• Site level study and/or territory information
• learning management system(s) compliance

 

Regional Site Manager knowldege


• Good understanding of Good Clinical Practices, ICH guidelines, ethics, patient privacy laws, EU Directive and other applicable local country regulations
• Good knowledge of concepts and understanding of clinical research and the drug development process
• General therapeutic area education and training

Key words monitoring, clinical site management, CRA, SCRA, senior clinical research associate, clinical research associate,  site manager, risk based monitoring, remote monitoring

Please call Marc Joseph on 44 (0)1753 216664 for further information or send your application to marc.joseph@chiltern.com

Apply for this job: Senior Clinical Research Associate (Regional Site Manager) - SCRA

Contact Information:

Address:  London, UK
Covance Clinical and Periapproval Services Ltd Osprey House Maidenhead Office Park Westacott Way Maidenhead
SL6 3QH
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.