Site Monitor II - FSP

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 payment status. Follow-up on CRF data entry, query status, and SAEs. Conduct on-site study-specific training (if applicable). Perform site facilities assessments Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution. Overall Accountabilities from Site Identification to Close out: Ensure timely and accurate completion of project goals and update of applicable trial management systems. Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. Ensure that assigned sites are audit and inspection ready Monitor and maintain compliance with ICH-GCP and applicable international and local regulations. Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance. Show commitment and perform consistent high-quality work. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, mode

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