Site Monitor II

2 semanas atrás


remote brazil Parexel Tempo inteiro

When our values align, there's no limit to what we can achieve.   Parexel is looking for multiple Site Monitors II (CRA II) in Argentina, Brazil and Mexico.  The Site Monitor II will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements.The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready. Key Accountabilities: Maintenance (from initiation through close out): Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. Build relationships with investigators and site staff. Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant. Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication. Address/evaluate/resolve issues pending from the previous visit, if any. Follow-up on and respond to appropriate site related questions. Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action. Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required. Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable. Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements. Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns. Conduct remote visits/contacts as requested/needed. Generate visit/contact report. Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff. Assess & manage test article/study supply including supply, accountability and destruction/return status. Review & follow-up site



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