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Labcorp Drug Development
Labcorp Drug Development Rueil-Malmaison France
1 week ago
Clinical Research Associate with Oncology experience / Dedicated to Sponsor- Paris area
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Your responsibilities:
• Own all aspects of site management as described in the project plans.
• Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.
• Protect study patients by... verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents. Monitor data for missing or implausible entries.
• Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Act as a primary contact for clinical trial suppliers and other vendors.
• Own the entire process of Serious Adverse Event (SAE) reporting
• Generate queries and resolve issues according to data review guidelines on sponsor data management systems
Experience:
• Solid independent monitoring experience in France as a CRA, with a focus on Oncology trials (Phase I experience would be a plus)
• Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the French regulatory authorities landscape
• IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF, CTMS, eCRF, IWRS experience
• Effective time management and organizational skills and a keen attention to detail
• Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
• Excellent communication skills in both French and English - spoken and written - are a must
This position can follow an hybrid model with office-based at client's site (94 department) with 2 days a week of teleworking or Home-Based with once a week in client's office.
Join Labcorp and benefit from flexible working hours, highly compensation packages, excellent training and career opportunities and more
We look forward to hearing from you
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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