Study Start-Up Coordinator - Paris Area (Sponsor-Dedicated)
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Our FSP department is currently looking for their next *Study Start-Up Coordinator *to join the team of a well-known sponsor located in the area of Paris (92).*Responsibilities : *
- Compile, submit and follow-up clinical trial submission applications to local Ethic Committee ( ANSM and CPP) and act as their main regulatory contact as well as for R&D teams* Participate in project team meetings to coordinate trial submissions* Ensure documentation and coordination of supply of investigational products.
- Support contract negotiator where necessary (e.g. CNOM)* Ensure quality control of documents submitted to Ethic Committee : review and validation of ICFs and all documents intended for patientsAll these activities are carried out in constant partnership with the project teams, in order to provide high-quality, proactive and proactive support.*Skills and requirements :
Academic educational background in Science* Perfect knowledge of current regulations (EUCTR) and clinical research procedures.
IT proficiency* Experience in managing various projects simultaneously* Rigour, organization, negotiation, interpersonal skills, diplomacy, ability to analyze and summarize* Excellent level in French and in EnglishDoes this sound appealing to you?
You can apply today !Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
For more information about Fortrea, visit www.fortrea.com (http : / / www.fortrea.com).*Fortrea is proud to be an Equal Opportunity Employer : *As an EOE / AA employer, Fortrea 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.
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fortrea.com / legal / privacy-policy).