Principal Clinical Research Associate
il y a 7 jours
Company Description
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,400 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
**Job Description**:
Make the right choice and take a **Principal CRA** role to train and mentor Clinical Operations team in France and supervise all clinical aspects of full-service global projects locally.
**You will**:
- Supervise study start-up, clinical monitoring and site management activities on a country/regional level
- Ensure ongoing evaluation of quality at a country/regional level
- Participate in site audits and other types of QC visits
- Support the project team in CAPA development and implementation
- Coordinate investigator/site identification process
- Facilitate start-up processes
- Review IP-RED/site regulatory packages and monitoring visit reports at a project level
- Monitor and facilitate query resolution processes
- Coordinate and monitor the safety information flow
- Act as a mentor for monitors
- Develop and deliver general and country-specific training for CO staff
**Qualifications**:
- Relevant educational background, such as MD, MPharm, RN or university/college degree in life sciences or an equivalent combination of education, training and experience
- Minimum 4 years' site monitoring experience
- Minimum 1 year experience as SCRA to demonstrate performance and ability to successfully mentor and train CO staff
- Full working proficiency in English and French
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
Additional Information
This is a great opportunity for you to develop new skillsets, while growing with the company.
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