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University leads major new research into wound care
17 September 2009
The University of York's Department of Health Sciences and NHS Leeds
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Covance
Clinical Research Associate
Clinical Research Associate 2
West Midlands
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Max Resourcing
Business Development Manager
Head of BD & Operations CEE
Rest of Europe
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| Company: |
Clinical Professionals |
| Category: |
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| Position: |
Senior Clinical Research Associate (SCRA) |
| Area: |
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| Location: |
Middlesex |
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| Notes: |
Company Summary
A fantastic opportunity to work as a office-based Senior Clinical Research Associate, in West London / Middlesex for a world leader in the field of biotechnology. The role presents the opportunity to work in a very supportive environment, with excellent access to training, in a company culture where leadership qualities are supported and nurtured.
Role Summary
To provide local site and study management and central co-ordination of the monitoring function from feasibility to study completion, across all regions, phases and therapy areas. To oversee the conduct of clinical trials at assigned trial sites, within the agreed time scale, by regular monitoring. Once responsibility has been assigned, the CRA is the primary contact between the trial site and Sponsor.
Role Description
* To liaise with the relevant drug safety department and the Medical Responsible in the management of serious adverse events and SAEs
* To assist in negotiating grants and contracts, and in budget forecasting and payments.
* To manage investigational medicinal product supplies at the country and assist in investigational medicinal product forecasting in accordance with study agreements.
* To assist in the preparation for trial site audits and inspections, and to participate in the audits and inspections
* To maintain/develop a good level of scientific knowledge within Sponsors therapeutic areas.
* To liaise with other CRAs to ensure harmony of standards and procedures and to contribute to the review (and drafting) of existing and new SOPs, Work Instructions and study specific conventions
* To undertake the role of CM Leader upon request. May involve assisting and overseeing other CRAs, CTCs and CTDCs if assigned
* To gain and/or demonstrate proficiency in electronic data capture
Qualifications and Experience
* Biological Science or similar /pharmacy/nursing degree or Nursing qualification.
* Higher Science degree eg MSc, PhD
* Significant level of UK or EU CRA experience or combination of CRA + other relevant experience (e.g. regulatory, clinical QA, pharmaceutical sales, study site coordinator).
* Phase I to IV experience.
* Experience of regulatory inspection, and experience of internal audit.
* Multinational experience.
* Involvement in protocol, CRF, other trial related document development.
Other Requirements
*Valid VISA / Permit to work in the UK (if applicable)
*Ability to work from home.
*Must have current valid UK / International driving licence.
*Be willing and able to travel (a commitment of up to 70% travel may be required).
Key Words: Senior Clinical Research Associate SCRA Clinical Development Biotechnology Research and Development R&D International Permanent Office Based Monitoring Middlesex West London Central London Surrey Berkshire South East Relocatable Hertfordshire UK |
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| Reference: |
J345935
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| Contact: |
Clinical Professionals |
| Phone: |
0118 959 4990 |
| Apply: |
Click Here
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