Clinical Research Associate - Paris
An international pharmaceutical company is advertising a vacancy for a Clinical Research Associate (CRA) based in their office in Paris. The organisation is known for their work in developing targeted therapies that treat diseases with high medical needs such as cancer, chronic inflammatory diseases, and neurological degenerative disorders. This is an exciting opportunity to work with a globally renowned organisation.
- Serve as main contact for assigned investigative sites.
- Responsible for representation in a professional manner.
- Complete site selection and pre-study activities to identify and evaluate potential investigators.
- Assist in site evaluation and report to Study Manager, as appropriate.
- Manage investigative site activity for multiple protocols/indications and provide ongoing updates of site status to study manager, ensuring compliance and understanding of study requirements by site staff.
- Assist with study start-up activities:
- collect, review, and track regulatory site documents
- conduct regulatory submissions to Ethic Committees and Competent Authorities
- assist with Contract and Budget negotiations
- Participate in study-specific training and attend Investigator meetings.
- Complete 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.
- Anticipate/identify site issues and study deviations.
- Implement corrective actions and a proper escalation to Study Manager, as necessary.
- Ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
- Attend global project team teleconferences and provide ongoing updates of site status to Study Manager.
- Maintain the CRO/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.
- At least 2 years of prior clinical monitoring experience.
- Good knowledge of applicable regulatory requirements in France.
- Proficient in the use of laptop computer and software systems (MS-Office package, eTMF, CTMS, etc).
- 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.
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 Valaince Penteng at +44 203 846 0643 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.