Clinical Research Associate (CRA) Level II – Cell Therapy/Oncology

About the role

We are seeking a Clinical Research Associate (Level II) to support innovative cell‑therapy and oncology trials. The CRA will conduct remote and on‑site monitoring visits, ensure compliance with protocols, ICH‑GCP and regulatory requirements, and help advance transformational treatments for patients.

Key responsibilities

• Perform risk‑based monitoring of investigator sites, applying root‑cause analysis and corrective actions.
• Verify data accuracy through source data verification (SDR), source data review (SDV) and case‑report‑form (CRF) review.
• Assess investigational product inventory and related documentation.
• Document observations in monitoring reports and letters, following approved business writing standards.
• Escalate deficiencies promptly and follow issues through to resolution.
• Maintain regular communication with sites between visits to ensure protocol adherence and timely data entry.
• Participate in investigator payment processes and investigator meetings.
• Identify and qualify potential investigative sites in collaboration with the sponsor.
• Initiate site set‑up, conduct trial close‑out activities and retrieve trial materials.

Required profile

• Experience in clinical monitoring of cell‑therapy or oncology studies.
• Strong knowledge of ICH‑GCP, regulatory guidelines and SOPs.
• Ability to conduct both remote and on‑site monitoring activities.
• Excellent analytical and problem‑solving skills, including root‑cause analysis.
• Effective written communication for report generation and issue escalation.

Required skills