🕒 yesterday
Conducts onsite clinical trial monitoring for Phase II and/or III studies, overseeing site communication, source data review, query resolution, study progress, regulatory submissions, and audit and inspection preparation.
Clinical Research Associate II/Senior CRA
🕒 yesterday
📍 🇫🇷 Saint-Maur-des-Fossés - Remote🎸 Senior🧫 Clinical Research Specialist📢 🇬🇧 English Required💼 Full-Time
Clinical ResearchOnsite MonitoringStudy StartupCRF Review
📜 Description
- Conduct and report onsite monitoring visits across clinical studies.
- Support study startup and participate in feasibility research.
- Review CRFs, verify source documents, and resolve queries.
- Manage site communications and serve as a contact for internal support services and vendors.
- Update internal project teams on study progress.
- Support the regulatory team with study submission documents.
🛠️ Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in France
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in oncology, hemophilia, infectious diseases, GI
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Please submit your CV/resume in English
✨ Benefits
- Mentorship and training program.
- Development opportunities across departments.
- Flexible working hours.
- Home-office option and home/office work arrangement.
- Onboarding and professional development training programs.
- Additional leave days (12 days of RTT).
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 22 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in France
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in oncology, hemophilia, infectious diseases, GI
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Please submit your CV/resume in English
Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
We offer:
- Big professional advancement opportunity within Clinical Operations with specific mentorship and training program
- Development opportunities across PSI departments
- Flexible working hours
- Home-office option available, as well as combination of home and office work arrangement
- Extensive onboarding trainings and professional development training programs
- Highly developed company culture and positive team atmosphere
- Additional leave days (12 days of RTT)
- Please submit your CV/resume in English
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