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Senior Clinical Research Associate

Il y a 4 mois


France, FR Meet Temps plein

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.