Clinical Research Associate (H/F)

Leading French independent pharmaceutical Company, specialised in ethical medicinal products. 92% of Servier’s sales are achieved internationally, with several subsidiary companies abroad. We are looking for V.I.E’s, for our subsidiary in Brazil. Description of the mission: Ensure running of clinical studies at the allocated sites according to technical protocol, Good Clinical Practice, local regulations and company’s SOPs.  Verifies and ensures the clinical study sites comply with the study technical protocol and other study related documents, Good Clinical Practice, local regulations and applicable SOPs;  Performs site initiation visits, clinical monitoring visits, site close out visits, as specified in the study-specific monitoring guide;  Ensure the data collected in clinical study sites correspond to the specified requirements (as per monitoring guidance and/or study monitoring plan), ensure data quality, authenticity and traceability.  Conducts Source documents review of appropriate source documents and medical records.  Verify required clinical data entered in the case report form (CRF) is accurate and complete.  To guarantee the Drug kits (DK) accountability during the study; regularly verify the storage, dispensation, retrieval and/or destruction of DKs;  Routinely reviews the Investigator Site file (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).  Supports subject/patient recruitment, retention and awareness strategies.  Help the clinical study sites with study logistics, facilitates resolution logistical problems, when required;  Reporting safety information on the company products in accordance with regulatory requirements and standard operating procedures. It is a mission for those who are motivated by impact on health, scientific rigor, Good Clinical Practice and teamwork collaboration.

• Academic Background: Master degree • Expertise: In life sciences, pharmacy, chemistry, public health, or related health fields. • Language Proficiency: English: Fluent (required) Portuguese: basic (required) / professional or fluent (Plus) • Professional Experience: Clinical trial monitoring, site management, patient recruitment • Technical Skills: GCP compliance, regulatory knowledge, data integrity, teamwork

Les études de conception, notamment au niveau des études Pre-cliniques et cliniques, l'organisation, la coordination, le développement et la planification de toutes études dans la recherche médicale et pharmaceutique, la recherche et l'exploitation de nouvelles orientations