Senior CRA II – Site Care Partner, Oncology

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site staff, offer recommendations, escalate significant issues, and formulate action plans.

• Confirm informed consent procedures, maintain patient confidentiality, and ensure the safety and integrity of clinical data.

• Evaluate site processes and perform source document reviews and medical record verifications.

• Address queries both remotely and on-site within the established timelines.

• Utilize hardware and software for reviewing and capturing clinical study data; ensure compliance with electronic data capture standards.

• Oversee the inventory, reconciliation, storage, security, dispensing, and compliance of investigational product administration.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities and maintain tracking systems effectively.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Manage site-level activities and communications to achieve project goals, deliverables, budgets, and timelines.

• Collaborate with study site personnel, ensuring that assigned sites and project-specific staff are properly trained and compliant.

• Participate in Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings, and training sessions.

• Facilitate audit readiness, prepare for audits, and follow up on action items post-audit.

• Provide guidance, training, and mentorship to junior CRAs; conduct training and sign-off visits.

• Support RWLP activities such as site support, chart abstraction, data collection, regulatory collaboration, site identification, process enhancements, consent form development, RFPs, budgeting, site management strategies, and CRF/edit-check development.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Moderate critical thinking skills.

• Capability to manage travel requirements of up to 75% regularly.

• Experience in oncology is preferred for this position, though not mandated as a requirement.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged leadership.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Reasonable accommodations available for employees or applicants with disabilities when appropriate.