CRA (Level II) - Marseille
Thermo Fisher Scientific
- France
- CDI
- Temps-plein
- Recognized for excellence in various categories in the 2023 CRO Leadership Awards: access to patient populations, data management and patient recruitment and for compatibility, including responsiveness, project communications and customer service. In addition, we were recognized for reliability and expertise.
- Named “Best Lab” at the 2023 Vaccine Industry Excellence (ViE) Awards
- Named a 2023 Training magazine APEX Award winner for effective employee development programs.
- Thermo Fisher Scientific’s Clinical Research Business Named “Best CRO”
- Recognized by ISG for digital services leadership
- Winner of the 2022 TOPRA Award for Regulatory Excellence with Moderna for work on a COVID-19 vaccine authorization
- Named to BioSpace’s 2023 Best Places to Work list
- Named “Clinical Research Company of the Year” at the 2022 PharmaTimes Clinical Researcher of the Year-The Americas competition
- Performs and coordinates all aspects of the clinical monitoring and site management process in compliance with the Regulatory approved Protocol and Monitoring Plan.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation.
- Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
- Develops collaborative relationships with investigational sites.
- Acts as a site Manager and processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
- Ensures audit / Inspection readiness.
- Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Valid driver's license
- Effective clinical monitoring skills with at least 1 year of monitoring experience
- Effective oral and written communication skills in French and English with the ability to communicate optimally with medical personnel and colleagues.
- Ability to travel and perform 8 days on Site per month on average.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
- Ability to handle Risk Based Monitoring concepts and processes.
- Strong attention to detail and time management skills
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Good presentation skills