CRA II - Paris

An international contract research organization (CRO) is seeking to recruit a CRA II to its office in Paris. The CRO delivers a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialisation. The organisation's focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise, along with access to a fully integrated multi-speciality clinical research site that conducts phase I-IV trials. This is an exciting opportunity to work with a company that provides life-changing therapies for critically ill patient populations.

Job Responsibilities:

• Serves as main company contact for assigned investigative sites. Responsible for representation of company in a professional manner.
• Completes site selection and pre-study activities to identify and evaluate potential investigators. Assists in site evaluation and reports to Study Manager, as appropriate.
• Manages investigative site activity for multiple protocols/indications and provides ongoing updates of site status to study manager, ensuring compliance and understanding of study requirements by site staff.
• Assists with study start-up activities: collects, reviews and tracks regulatory site documents, assist in regulatory submission process to Ethic Committees and Competent Authority; and Contract and Budget negotiation.
• Participates in study-specific training and attends Investigator meetings.
• Completes monitoring visits and routing 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.
• Anticipates/identifies site issues and study deviations. Implements corrective actions and a proper escalation to Study Manager, as necessary
• Ensures proper storage, dispensation and accountability of all investigational product(s) and trial-related material
• Attend to global project team teleconferences and provides ongoing updates of site status to Study Manager. Maintain company/Sponsor project tracking systems, as required
• Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.

Skills and Requirements:

• Bachelor's or Master's Degree in allied health fields, such as Health/Natural sciences, Pharmacy, or Nursing.
• 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.
• Good Knowledge in applicable regulatory requirements in France.
• Proficient in the use of laptop computer and software systems (MS-Office package, eTMF, CTMS, etc)
• Excellent communication, presentation, interpersonal skills in English and French, are essential
• Reliability and a good sense of team working
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Theodora Savlovschi-Wicks at +44 203 752 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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