Senior Clinical Research Associate

Join Oracle Life Sciences, a global leader in cloud technology, pharmaceutical research, and consulting trusted by professionals worldwide.

We are dedicated to advancing clinical development and improving patient outcomes through innovative solutions and real-world evidence.

With a focus on groundbreaking developments in Oncology and Rare Disease, alongside the integration of technology into medicine, there's never been a more exciting time to work in Life Sciences.

 If you're seeking to expand your expertise and make a difference, join us and empower our clients and patients globally.

 

Career Level - IC2

What you will do

As a Sr. Clinical Research Associate, you will play a vital part in supporting the Project Team throughout all stages of the study cycle in France and potentially in Belgium, Switzerland and Luxembourg (French-speaking regions). You'll closely collaborate with an international team based in the US and across Europe.

This position requires minimal travel around 3 visits per month and focuses on Real-World Evidence studies (Observational, Non-interventional, Post-marketing studies).

•  Conduct site initiation (SIV), routine monitoring (phone/video calls, onsite visits), and close-out visits (COVs) in accordance with study protocols, SOPs, and applicable regulations. Most of visits are conducted remotely.
• Participate in site feasibility assessments and selection, including evaluating site capabilities and resources.
• Assist in the preparation and submission of regulatory documents.
• Site monitoring, including source document review and verification (SRD/SDV). Oversight of patient enrollment, and sites’ adherence to study procedures and timelines.
• Communicate effectively with site staff and investigators to address queries, provide training, and ensure study progress.
• Manage contract execution and oversee the processing of site payments.
• Maintain study (TMF) and site files (ISF) in accordance with regulatory requirements and company standards.
• Participate in regular study team meetings and provide updates to the Project Team on the progress of assigned sites in France, Belgium Switzerland and Luxembourg (French-speaking regions).
• Ensure timely documentation of all study-related activities, including monitoring reports, correspondence, and maintenance of site trackers.
• Contribute to developing and implementing process improvements to enhance study efficiency and quality.

 

Required Experience

•  Master’s degree in a scientific or healthcare-related field (Biology, Biochemical, Biotechnology, etc).
• Minimum of 3 years experience as a CRA working with French sites.
• Comprehensive understanding of regulatory requirements in France and experience in preparing regulatory submissions.
• Strong self-organizational and communication skills.
• Attention to detail and ability to work independently.
• Ability to work collaboratively within a dynamic international team.
• Fluent in written and verbal English and French both C1 level as a minimum.

As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. 

We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.