Covance Sr Clin Res Assoc in Maidenhead, United Kingdom
Chiltern, a Covance company is 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 SCRA to the team, starting January/February 2019.
Full Time ideally.
Risk Based/Remote Monitoring - UK wide site coverage.
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.
Relatively minimal travel required as the model is REMOTE/RISK based monitoring.
PLEASE NOTE - it is ESSENTIAL that you have a pharma or CRO monitoring background.
T asks 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
Please call Marc Joseph on 44 (0)1753 216664 for further information or send your application to email@example.com
Education / Qualifications
Life Scienr Degree or Equivalent.
Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)
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
• 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
Key words monitoring, clinical site management, CRA, SCRA, senior clinical research associate, clinical research associate, site manager, risk based monitoring, remote monitoring
Job Number 2018-26196
Job Category Clinical Research Associate
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.