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Senior Clinical Research Associate (Sr. CRA)

Chicago, IL 60632

Posted: 11/07/2025 Employment Type: Direct Hire Job Category: Operations and Development Job Number: 4636

Job Description

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 SOPs and related study monitoring plans.  

Responsibilities:
  • 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.
Qualifications:
  • 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 the 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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