Clinical Research Associate II
An amazing opportunity has arisen at a Contract Research Organisation (CRO) for a Clinical Research Associate II (CRA II) to join their team in Paris. If you're interested in changing the face of medicine, then this is the role for you.
- Performs site qualification, site management activities and close-out visits ensuring Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Immediately communicates serious issues to the project team and develops action plans.
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Understands project scope, budgets, and timelines; manages site-level activities and communication to ensure project timelines are met.
- Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Site support throughout the study lifecycle from site identification through close-out
- Chart abstraction activities and data collection
Skills and Requirements
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
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
Manon Madelenat on +33188880096 or upload your CV on our website - www.proclinical.com/send-cv
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