Job Title: Senior Clinical Research Associate - SCRA - Hertfordshire
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Vacancy details
Vacancy description:
Job Code:
J690722
Job Title:
Senior Clinical Research Associate - SCRA - Hertfordshire
Job Category:
Clinical Research
Contract:
Locum/Temporary
Discipline:
CRA
Country:
United Kingdom
Location:
Bedfordshire, Buckinghamshire, Hertfordshire, London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Senior Clinical Research Associate - SCRA - Hertfordshire
A fantastic opportunity to join a rapidly expanding novel biotechnology company based in Hertfordshire. With an excellent potential to gain broad experience with a friendly and flexible company, this is an opportunity not to be missed.
Key Duties and Responsibilites:
Clinical Trial Monitoring services in collaboration with the Associate Director of UK Clinical Trials Operations to ensure start-up, recruitment, conduct and monitoring of agreed clinical trials within the companys portfolio in the United Kingdom.
Including but not limited to:
• Preparation of ethics submissions of protocols and amendments
• Preparation and collection of essential documents as required
• On-site monitoring (incl. source data verification, review and collection of CRFs) according to ICH-GCP guidelines and relevant SOPs and monitoring guidelines.
• Reporting and follow-up of any outstanding issues from the visits.
• Telephone and on-line communication with staff and sites as required.
• Training on trial documents, SOPs and literature, communication with staff for questions, clarifications before and during the course of the trials.
• Participation in any relevant Investigator’s and CRA meetings.
• Update tracking systems for patient recruitment and follow-up on study status
• Ensure full monitoring of AEs and SAEs and follow-up on these events (in cooperation with Safety Dept.).
• Help ensure that all UK SUSARs are reported to the Main RECs within the required timelines.
• Forward monthly line listing of all SUSARs to the UK investigators.
Keywords: SCRA Senior Clinical Research Associate Full-Time Biotechnology Pharmaseutical Research and Development R&D Clinical Trials Clinical Development Clinical Research Hertfordshire Herts Bedforshire Middlesex East Berkshire London North London South East UK Anywhere England (all)
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