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Senior Clinical Research Associate (US) Remote Position Summary The Sr. CRA is responsible for the oversight and monitoring clinical trials to ensure they are conducted in compliance with the study protocol, ICH-GCP guidelines, applicable regulations, and company SOPs. The Sr.

CRA provides CRO oversight or monitoring of site performance, data quality, patient safety, and timely trial execution through effective site management and communication. The Sr. CRA supports the Clinical Trial Manager in oversight of CRO.

This individual will contribute to the success of the team and organization by delivering on role-specific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement. Key Responsibilities Site Management & Monitoring Conduct targeted oversight or monitoring activities for site selection, initiation, interim monitoring, and close-out visits Ensure trial conduct aligns with protocol, ICH-GCP, and regulatory requirements Oversee review and verify source data and ensure accurate, complete, and timely data entry Perform risk-based monitoring activities (remote and on-site as required) Training and escalation for CRO CRAs when necessary KPI and QTL review and updates to ensure the trial is operating at the highest quality Develop and review tools to support the monitoring or oversight of the CRO Proactively escalation to the CTMs/PD any deficiencies encountered in their daily work. Regulatory & Documentation Ensure essential documents are complete and filed appropriately (TMF/CIF/ISF) Support regulatory submissions and maintenance of site documentation Confirm proper informed consent processes are followed and documented Data Quality & Safety Identify and resolve data discrepancies with site staff and data management Support safety reporting processes (AEs/SAEs) and follow-up documentation Escalate quality issues and support CAPA implementation when needed Serve as primary point of contact for assigned sites, proactively address issues and provide solutions.

Provide training and ongoing support to investigators and site teams Collaborate with cross-functional teams (Clinical Ops, DM, Safety, QA) Vendor and Study Support Coordinate with central labs, imaging, and other trial vendors as needed Track site performance metrics (enrolment, deviations, query resolution) Support study timelines and contribute to process improvements Oversight of CRA activities provided by third party Review CRO deliverables such as monitoring visit reports, follow-up letters, trip reports, and site communication for quality and completeness Track CRO performance using agreed metrics (e.g., monitoring visit timeliness, query aging, protocol deviation, TMF completeness) Escalate site and CRO issues as needed and contribute to issue management and resolution plans Participate and attend vendor meetings and have flexibility to support the team travelling abroad. Support oversight of TMF/eTMF completeness and filing practices, including CRO-generated documents Ensure CRO monitors are complying to risk-based monitoring plans and study-specific monitoring requirements Support audit/inspection readiness by ensuring CRO monitoring documentation and site files are inspection-ready Assist with review of CRO training compliance for assigned sites/staff Skills and Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field 10+ years of CRA or Clinical research experience Familiarity with ICH-GCP, UK/US/EU regulations, and clinical trial documentation Excellent organizational and time management skills Strong interpersonal and communication skills. Ability to work independently and manage multiple sites Ability to work across time zones Experience in Oncology preferably hematological cancers Proven ability to build trust and credibility through integrity, openness, and respect.

Demonstrated accountability in delivering results and meeting commitments. Analytical mindset with the ability to use facts and data to guide decisions. Experience working on phase 2 and 3 registrational trials is preferred Working Behaviors (Core Expectations) Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.

Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback. Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals. Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.

Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential. #J-18808-Ljbffr