.mexico, remote*job id* r0000020557*category* clinical trials*about this role*:parexel fsp is hiring a site monitor to support the mexico region.the site monitor 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*:*start-up (from site identification through pre-initiation)*:act as parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.- build relationships with investigators and site staff.- conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:- preparation, negotiation, and facilitation of execution of confidentiality agreements (cda), clinical site agreements (csas) and any amendments.- conduct remote qualification visits (qvs).- generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.- develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (srp) and any updated or amended regulatory documentation.- customize, review, and negotiate as needed, country/site specific informed consent forms (icf), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.- submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.- forecast, develop, manage, and revise plans and strategies for:- irb/iec and moh / ra submission/approval,- site activation,- patient recruitment & retention.- update and maintain appropriate clinical trial management systems (ctms) in a timely manner.- promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.- facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.- actively participate in investigator and other external or internal meetings, audits & regulatory inspections- work in a self-driven capacity, with limited need for oversight.- proactively keep manager informed about work progress and any issues