Experimented CRA France - single sponsor

Syneos Health France SARL; France; Hybride; EUR 42 000 - 62 000; Plein temps

Résumé du poste

Syneos Health France SARL is seeking an experienced Clinical Research Associate (CRA) to monitor oncology and other studies across sites in France. You will conduct on-site and remote monitoring, ensure adherence to GCP, and contribute to study documentation and quality improvements.

With 2–4 years of clinical research monitoring experience, you will work independently within a cross-functional team, manage multiple priorities, and use CTMS and other software to support trial operations.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Minimum of 2-4 years of experience in clinical research monitoring.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple priorities.
• Proficiency in using clinical trial management systems and other relevant software.

Responsabilités

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms.
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates.
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials.
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress and resolving issues.
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans.
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct.

Connaissances

GCP knowledge

Communication skills

Independent working

Time management

Clinical trial systems

Team collaboration

Formation

Bachelor's degree in related field

Outils

CTMS

Description du poste

Experimented CRA France - single sponsor Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms.
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates.
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials.
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress and resolving issues.
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans.
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Minimum of 2-4 years of experience in clinical research monitoring.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple priorities.
• Proficiency in using clinical trial management systems and other relevant software.

Certifications

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred.

Necessary Skills

• Attention to detail and strong analytical skills.
• Problem-solving abilities and critical thinking.
• Ability to work effectively in a team environment.
• Strong organizational and time management skills.
• Proficiency in Microsoft Office Suite.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients.

We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.

The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.

A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to:

• Partner with the most diverse team of experts in the industry.
• From the top down, our people are inspiring.
• Everyone has a voice and is encouraged to use it.
• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.
• With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
• We are partners with purpose.
• We integrate seamlessly with our customers and do what’s best for their success.
• Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.