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Job Details

Senior CRA/SCRA UK

Company: Chiltern
Location: Flexible UK
Reference: MLJALL1
Closing Date: 08 Jul 18
Type: Full Time
Salary (£): Negotiable
Benefits: Flexible Benefits to include 25 days leave, car or allowance, pension, LI, gym membership contribution, healthcare benefits

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 two more SCRAs to the team, starting September and October. Full Time. Home Based. Risk Based Monitoring and site management

Requirements:

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, ideally we would look at Midlands but we are flexible on this.

Current studies are in Gastointestinal and Diabetes - you would be involved from site initiation onwards.

UK wide travel is required.

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

Please see below a summary of the expectations of the regional site manager.

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

Competencies/Skills:
• Cross Functional Relationships     Skilled
• Communication Skills      Highly skilled
• Decision Making       Skilled
• Execution/Results/Process Improvement    Skilled
• Interpersonal skills       Skilled

• Ability to handle and prioritise multiple therapeutic areas and projects simultaneously
• Self-starter with ability to work independently in a regional area with remote or minimal supervision
• Ability to work effectively in a team/matrix environment
• Ability to influence others without direct reporting relationships
• Ability to understand technical, scientific and medical information
• Demonstrated strengths in the following areas:
• Planning, organizational, project management and analytical skills
• Oral and written communication
• Time management
• Negotiation
• Conflict management and resolution
• Problem solving
• Attention to detail
• Interpersonal and networking skills
• Relationship building
• Motivational skills
• Cross-cultural sensitivity
• Clinical study budgets
• Customer Service Orientation

Other:
• Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)

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

Please contact Marc Joseph - marc.joseph@chiltern.com or call Marc on 01753 216664 for further information/application.

Apply for this job: Senior CRA/SCRA UK

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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