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Job Details

Clinical Research Associate Site Manager

Company: Chiltern
Location: Anywhere in the UK
Reference: MLJ899086
Closing Date: 21 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Excellent Home Based SCRA level opportunity.Global Healthcare Company.Anywhere in UK.

Requirements:

Job Background

Chiltern are currently in a strategic partnership with a global healthcare company. 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. YOU would be EMPLOYED by Chiltern 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 scenario is called a CRA Site Manager

One of the big advantages of this model is job security and a culture were contract CRAs (RSMs) are treated and respected as if they were permanent employees of the healthcare company. The role will offer potential career opportunities. Also the SOPs are very TOP LINE so there is flexibility to work in a creative way and you would not be tied up in red tape, and convoluted systems and processes.

There is a very good benefits package to include minimum of 25 days leave (increasing to 30) and the ability to buy extra leave – up to 40 days, PLUS a salary sacrifice scheme – tax efficient way of increasing your pension pot.

In terms of location, we will look at anywhere in England or Wales, and also Southern/Mid Scotland.

Sites have yet to be determined in the UK but 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 monitor.

Tasks and Responsibilities of the CRA 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 following factors will be taken into account in determining the duration of each monitoring visit: preparation time required, travel time, number of patients on-going at the site, number of data queries to be resolved, the extent of reporting necessary as well as follow-up. Where possible, visits to distant sites, which are geographically close to each other, will be made on consecutive days in order to make most efficient use of time.

The CRA 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


CRA Site Manager Knowledge:
• 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)



 

Salary

On Application

Position Type

Permanent
Full Time

Contact

Email Marc Joseph - marc.joseph@chiltern.com
01753 216664

Apply for this job: Clinical Research Associate Site Manager

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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