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Clinical Research Specialist
Il y a 2 mois
Clinical Research Specialist
Location: Various locations across France
About Us:
We are a prominent global Clinical Research Organization focused on propelling medical advancements through groundbreaking research and development. Our mission is to enhance patient outcomes and conduct high-caliber clinical trials. Our team collaborates with leading pharmaceutical firms to introduce innovative therapies to the market. As we expand, we are looking for skilled and dedicated Clinical Research Specialists to join our vibrant team in France.
Position Overview:
In the role of Clinical Research Specialist, you will be instrumental in overseeing and monitoring clinical trials, ensuring adherence to regulatory standards, and aiding in the creation of transformative therapies. Your responsibilities will include managing multiple study sites, upholding the utmost standards of data accuracy, and nurturing robust relationships with site personnel and investigators.
Key Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with ICH-GCP guidelines, company SOPs, and regulatory standards.
- Manage all facets of site operations, including maintaining study documentation, coordinating with vendors, and ensuring timely participant recruitment and retention.
- Safeguard the welfare of study participants by confirming compliance with informed consent protocols and study requirements.
- Thoroughly review and resolve case report forms (CRFs), data inquiries, and adverse event documentation.
- Provide mentorship and support to junior staff, fostering an environment of continuous learning and professional growth.
- Act as the primary liaison for site personnel and investigators, addressing any concerns or issues in a timely and effective manner.
- Ensure readiness for audits at the site level and assist with regulatory evaluations as necessary.
Qualifications:
- Bachelor's or Master's degree in a life science or a related discipline.
- A minimum of 3-5 years of experience as a Clinical Research Associate, demonstrating a successful history of managing and monitoring clinical trials across various phases.
- Comprehensive understanding of ICH-GCP guidelines, regulatory standards, and SOPs.
- Exceptional organizational and time-management abilities, capable of handling multiple priorities and meeting deadlines.
- Outstanding communication and interpersonal skills, with proficiency in both French and English.
- Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other pertinent software.
- Willingness to travel extensively within France and occasionally abroad.
What We Offer:
- Competitive salary and a comprehensive benefits package.
- Opportunities for career progression and professional development.
- A supportive and collaborative work environment.
- The opportunity to engage in innovative clinical trials that significantly impact patients' lives.
- Flexible working arrangements, including options for remote work.
