The Sr CRA will be responsible for monitoring clinical studies at the site level ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The Sr CRA will perform site qualification visits, study start-up activities, protocol implementation, on site monitoring, and close out activities as assigned and in accordance with Xeris SOPs and related study monitoring plans.
Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan.
Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data.
Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF).
Conducts Investigational Product (IP) review and accountability on site.
Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues.
Maintains routine contact with investigator sites between routine on site monitoring visits.
Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions.
Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF.
Manages query resolution with investigator sites and data management operations.
Supports centralized risk-based monitoring oversight activities as assigned.
May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans.
Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs.
Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable.
May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency.
Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable.
Performs other tasks or responsibilities as assigned.
Bachelor's degree (B.A./B.S.) or equivalent in life sciences or related discipline.
6+ years' experience as a Clinical Research Associate.
Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities.
Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.).
Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.).
Ability to work independently and as part of a team.
Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications.
Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 75%.
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