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Senior Clinical Research Associate
Il y a 4 mois
Senior Clinical Research Associate (Senior CRA)
Location: Multiple locations across France
About Us:
Join a leading global Clinical Research Organization dedicated to advancing medical science through innovative research and development. We are committed to improving patient outcomes and delivering high-quality clinical trials. Our team of experts collaborates with top-tier pharmaceutical companies to bring cutting-edge therapies to market. As we continue to grow, we are seeking experienced and passionate Senior Clinical Research Associates (Senior CRAs) to join our dynamic team in France.
Position Overview:
As a Senior CRA, you will play a pivotal role in managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and contributing to the development of life-changing therapies. You will be responsible for overseeing multiple study sites, maintaining the highest standards of data integrity, and fostering strong relationships with site staff and investigators.
Key Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP guidelines, company SOPs, and regulatory requirements.
- Oversee all aspects of site management, including maintaining study files, liaising with vendors, and ensuring timely recruitment and retention of study participants.
- Ensure the protection of study participants by verifying adherence to informed consent procedures and protocol requirements.
- Perform thorough review and resolution of case report forms (CRFs), data queries, and adverse event reports.
- Provide mentorship and guidance to junior CRAs, fostering a culture of continuous learning and professional development.
- Act as the primary contact for site staff and investigators, addressing any issues or concerns promptly and effectively.
- Ensure audit readiness at the site level and assist with regulatory inspections as needed.
Qualifications:
- Bachelor's or Master's degree in a life science or related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate, with a proven track record of managing and monitoring clinical trials in various phases.
- In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and SOPs.
- Strong organizational and time-management skills, with the ability to manage multiple priorities and meet deadlines.
- Excellent communication and interpersonal skills, with fluency in both French and English.
- Proficiency in using clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.
- Willingness to travel extensively within France and occasionally internationally.
What We Offer:
- Competitive salary and comprehensive benefits package.
- Opportunities for career advancement and professional development.
- A supportive and collaborative work environment.
- The chance to work on innovative clinical trials that make a real difference in patients' lives.
- Flexible working arrangements, including remote work options.