Senior Clinical Research Associate
Current• Assesses site qualification potential: reviews study requirements, conducts pre-study visits and drafts pre-study evaluation reports.• Participates in the implementation of clinical studies: communicates with investigators and their staff; ensure compliance with terms and conditions; properly train site personnel and write visit reports.• Supervises the conduct of clinical studies: acts as a liaison between site personnel and the sponsor; performs clinical monitoring in the field; ensures compliance with protocols, regulatory requirements, and Good Clinical Practices (GCP, GxP); writes follow-up visit reports.• Ensures the quality of the project: verifies materials and data integrity (SDV); assists site personnel with internal audits or regulatory inspections; and performs ongoing follow-up with in-house project teams.• Closes clinical studies: verifies the integrity of the investigator files (ISF); ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.• Visits trial sites according to the monitoring plan.• Acts as a liaison between study managers and research site personnel.• Maintains the quality of the clinical trials and compliance with established timelines.• Ensures harmonization of in-house monitoring practices.• Adheres to protocol requirements, Good Clinical Practice (GCP, GxP) guidelines, FDA regulations (21 CFR), and standard operating procedures (SOP).• Assesses the trial site and applicable personnel on an ongoing basis.• Ensures compliance with the patient consent process.