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Senior Clinical Research Associate
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Job Title: Oncology Clinical Research Associate (CRA)
Location:
Paris, France
Department:
Clinical Operations
Reports to:
Clinical Project Manager (CPM) / Director of Clinical Operations
About Us
As a global leader in providing outsourced clinical development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries, we are dedicated to delivering high-quality solutions to bring life-saving treatments to patients. Our oncology team plays a crucial role in advancing cutting-edge cancer therapies, and we are expanding our clinical operations in Paris.
Job Summary
We are looking for a dynamic
Oncology Clinical Research Associate (CRA)
to join our team in Paris. As a CRA, you will be responsible for the monitoring and management of oncology clinical trials, ensuring the highest levels of compliance, quality, and patient safety. This is an exciting opportunity to work with top-tier pharmaceutical companies and contribute to the development of innovative cancer therapies.
Key Responsibilities
- Clinical Trial Monitoring
: - Conduct on-site and remote monitoring visits, including site qualification, initiation, monitoring, and close-out visits for oncology clinical trials.
- Ensure proper site conduct and compliance with study protocols, ICH-GCP guidelines, and local regulatory requirements.
- Review and verify case report forms (CRFs), patient data, and site documents to ensure data integrity and completeness.
- Ensure timely and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and other critical information.
- Site Management
: - Establish and maintain strong relationships with investigators and site staff to ensure site recruitment, training, and ongoing study performance.
- Provide ongoing site support and troubleshooting during the trial to resolve any operational or regulatory issues.
- Monitor the performance of the sites and ensure patient recruitment goals and timelines are met.
- Collaboration & Reporting
: - Collaborate with project teams, including Clinical Project Managers (CPMs), data management, and regulatory teams, to ensure smooth trial operations.
- Prepare, review, and submit monitoring visit reports and other required documentation in a timely manner.
- Ensure adherence to study timelines and deliverables while maintaining the highest standard of data quality and compliance.
- Study Documentation & Compliance
: - Ensure that all study-related documentation is accurate, complete, and maintained in compliance with local regulatory requirements.
- Support audits and inspections by regulatory authorities, ensuring compliance with GxP (Good Clinical Practice) and applicable local regulations.
- Continuous Learning & Development
: - Stay updated with the latest oncology trends, protocols, and clinical trial methodologies.
- Participate in internal and external training sessions and workshops to continuously enhance knowledge in oncology research and clinical trial processes.
Qualifications & Requirements
- Education
: - Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field. Advanced degrees (e.g., MSc, PhD) in oncology or related fields are a plus.
- Experience
: - Minimum 5 years of experience as a Clinical Research Associate (CRA) in oncology clinical trials, with a proven track record of managing and monitoring phase II and III oncology studies.
- Experience with multiple oncology indications such as solid tumors, hematologic malignancies, and immuno-oncology therapies is highly desirable.
- Technical Skills
: - Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial monitoring processes.
- Ability to manage multiple sites and studies simultaneously.
- Experience with eCRF systems and other clinical trial management tools (CTMS, EDC).
- Language Skills
: - Fluency in French and English (both written and spoken) is required.
- Knowledge of additional languages is a plus.
- Other
: - Strong attention to detail, organizational skills, and the ability to work independently and as part of a team.
- Excellent communication and interpersonal skills with the ability to build relationships with investigators and other site personnel.
- Willingness to travel (approximately 50-60% of the time).
What We Offer
- Competitive salary and benefits package.
- Flexible work schedule with opportunities for home-office work.
- Career development and growth opportunities with access to ongoing training and mentorship.
- A collaborative, innovative, and supportive work environment.
- Opportunities to contribute to the advancement of oncology therapies that will make a difference in patients' lives.
