CRA II - London

A new job opportunity has arisen for an exciting CRA II position a global, privately held, full-service contract research organization (CRO) that provides a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. Proclinical is advertising this position for an enthusiastic and hard-working individual to join this exciting company's office based in London.

Job Responsibilities:

• Serving as the main company contact for assigned investigative sites and taking responsibility representing the company in a professional manner.
• Completing site selection and pre-study activities to identify and evaluate potential investigators.
• Assisting in site evaluation and reporting to Study Manager, as appropriate.
• Managing investigative site activity for multiple protocols/indications, and providing ongoing updates of site status to the study manager, ensuring compliance and understanding of study requirements by site staff.
• Assisting with study start-up activities; collecting, reviewing and tracking regulatory site documents, assisting in regulatory submission processes to Ethics Committees and Competent Authority, along with Contract and Budget negotiations.
• Participating in study-specific training and attending Investigator meetings.
• Completing monitoring visits and routine monitoring activities to ensure the integrity completeness and accuracy of clinical data and appropriate follow-up of study procedures, including source document verification and SAE reporting in accordance with the Project Plan, Study protocol, GCP/ICH Guidelines, and applicable Regulations.
• Anticipating site issues and study deviations; implementing corrective actions and a proper escalation to Study Manager, as necessary.
• Ensuring proper storage, dispensation, and accountability of all investigational products and trial-related material.
• Attending to global project team teleconferences, and providing ongoing updates of site status to Study Managers. Maintaining company/Sponsor project tracking systems, as required.
• Completing assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs), and any applicable local regulatory requirements.

Skills and Requirements:

• At bachelor's or Masters' degree in a health-related field.
• Research Nurse RN or study coordinator or 3-year Nursing Diploma with at least 2 years of clinical nursing experience.
• At least 2 years of prior clinical monitoring experience.
• A strong knowledge in applicable regulatory requirements in Italy.
• Proficiency in the use of computer software systems.
• Excellent English communicative skills, along with interpersonal skills.
• Excellent organisational skills; an ability to work independently and in a team.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 0203 752 0314 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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