Covance Sr Clin Res Assoc in Maidenhead, United Kingdom

Job Overview

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.

Home Based.

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 marc.joseph@chiltern.com

Education / Qualifications

Life Scienr Degree or Equivalent.

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

Experience

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

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

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