Senior Clinical Research Associate (CRA)

Role Summary

The Senior Clinical Research Associate (CRA) monitors clinical studies at the site level to ensure adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The role includes site qualification visits, study start-up activities, protocol implementation, on-site monitoring, and close-out activities in line with SOPs and 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, focusing on participant safety, data integrity and regulatory compliance; ensures 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.
• Acts as point of escalation for clinical site management and investigator sites; liaises with in-house CRA to support communications and issue resolution.
• 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 sites as required and ensures corrective actions are implemented.
• Ensures all essential documents are complete and in place, filed to the eTMF and inspection-ready; participates in eTMF QC activities and ensures ISF-eTMF consistency.
• 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, forecast site visits, and overall clinical monitoring plans.
• Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs.
• Supports maintenance of documentation to clinical systems (CTMS, EDC, IRT) and related supporting documents in collaboration with study team members and external vendors as applicable.
• May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. for continual improvement and efficiency.
• Supports audits/inspections/inspection readiness activities by collaborating with relevant clinical sites to prepare for and respond to findings from internal QA or external regulatory agencies.
• 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 (CTMS, EDC, eTMF, etc.).
• Strong computer skills, including proficiency in Microsoft Office Suite.
• 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: Hybrid role based in Chicago with travel up to 75%; periodic evening/weekend work and overnight travel may be required.