Freelancer profile translated to English.
Back to original languageAbout Sara
Freelance Clinical Research Associate, specializing in oncology, I support CROs, pharmaceutical companies, and academic sponsors in conducting and securing their clinical trials, from the setup phase to closure.
With proven experience in multicenter clinical trials (phases I to IV), I provide immediate operational support, with a clear objective: to ensure data quality, regulatory compliance (GCP/ICH), and adherence to deadlines.
I assist my clients with on-site and remote monitoring missions, TMF management and review, investigator site monitoring, study coordination, clinical data management, adverse event monitoring, and preparation and support for audits and inspections. I also produce operational deliverables: monitoring plans, trackers, follow-up tables, reporting, and essential documentation.
My specialization in oncology and biotherapies allows me to quickly understand the scientific, regulatory, and field challenges of your projects, and to provide concrete and adapted solutions for demanding environments.
Recognized for my rigor, autonomy, and ability to integrate quickly, I work in close collaboration with project, data management, and regulatory teams, both in France and internationally.
👉 Looking for a reliable, experienced, and results-oriented freelance CRA, capable of securing your clinical trials and strengthening your teams without delay? I will support you on your projects with commitment and efficiency.
English
Native or bilingual
Spanish
Basic
Arabic
Fluent
Can work on-site
Paris (up to 50km)
Experience
- LYSARCSenior Clinical Research AssociateMEDICALMarch 2022 - June 2025 (3 years and 3 months)Paris, FranceCRA Missions: clinical trial setup, data monitoring, collection and writing of essential documents to ensure the smooth running of the study (SOPs, tracking table...), clinical trial closure, application of GCP and current regulations, monitoring of serious adverse events.
- Association pour la Recherche de Thérapeutique InnovanteClinical Research InternMEDICALJanuary 2014 - December 2015 (1 year and 11 months)Paris, FranceMissions: Data collection from medical records, Data entry, Data analysis on breast cancer at HEGP.
- Institut des Maladies Rares et GénétiquesClinical Research Associate & Project AssistantMEDICALNovember 2016 - February 2022 (5 years and 3 months)Paris, FranceACP Missions: Assistance in preparing files for substantial amendments, protocol amendments for regulatory submissions, monitoring of protocol amendments and associated documents, support for audits and inspections, clinical study coordination (Phase I-III), organization and minutes of project meetings, verification of eTMF updates, monitoring of CRA trackers and monitoring tables, correction of CRA reports, training of junior CRAs, assistance in resolving issues encountered by CRAs, management.CRA Missions: clinical trial setup, data monitoring, collection and writing of essential documents to ensure the smooth running of the study (SOPs, tracking table...), clinical trial closure, application of GCP and current regulations, monitoring of serious adverse events.
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Education
- Training: Clinical Research Associate and VigilanceFor Drug Consulting2016Formation : Attachée de Recherche Clinique et vigilance
- Master 1 and 2: Tissue, Cellular and Gene BiotherapiesL'Université Sorbonne Paris Nord et Paris 122015Master 1 et 2 : Biothérapies Tissulaire, Cellulaires et Génique
Skill set
Categories
- Other