Location: Anywhere in UK
Closing Date: 02 Jan 17
Salary (£): Competitive
Benefits: Very Competitive PAYE salary and benefits to include minimum 25 days leave, pension, LI, health benefits, gym membership contribution
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 regional site monitor (RSM)
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 RSM
• 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 RSM 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
• 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
• 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
• 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
• Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)
Please contact Marc Joseph on 01753 216664 for further information or send your CV directly to firstname.lastname@example.org. Alternatively please apply through this website.
Key words, monitor, monitoring, clinical site monitor, clinical research associate, CRA, senior clinical research associate
171 Bath Road Slough Berkshire
SL1 4AA, UK
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