17 sep
|
Jobrapido
|
Barcelona
17 sep
Jobrapido
Barcelona
Overview
You will support clinical development as a site-focused CRA across multiple therapeutic areas from home-based Spain. You'll drive site monitoring, ensure GCP/ICH compliance, and manage data quality while coordinating with cross-functional teams. The role blends investigator relations, regulatory tracking, and TMF/ISF maintenance to sustain study integrity. This position offers exposure to oncology, hematology, and cardiovascular trials within a collaborative, agile culture. You will contribute to delivering reliable data to accelerate patient access to innovative treatments.
Responsabilidades
- Perform a range of site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulations (GCP/ICH)
- Collaborate with sites to recruit subjects, tracking the recruitment plan to improve predictability
- Provide protocol training and maintain regular communication with sites to manage study expectations and issues
- Assess site practices for protocol compliance and data integrity; escalate quality issues as needed
- Track regulatory submissions, approvals, recruitment, CRF completion,
data queries, and study progress
- Ensure TMF/ISF documents are available and maintained per GCP and local requirements
- Document site management activities, site visit findings, and action plans with reports and follow-up letters
- Collaborate with study team members to support project execution
- May support site-specific recruitment planning and, where applicable, site financial management per contract
Requisitos principales
- Bachelor on scientific discipline or health care preferred
- At least 1.5 years of on-site monitoring experience
- Equivalent combination of education, training and experience considered
- Strong organizational, time management and problem-solving skills
- Ability to establish effective working relationships with colleagues, managers, and clients
- Flexibility to travel and valid driver's license
- strong communicator
- collaborative
- adaptable
- GCP/ICH knowledge
- site monitoring and management
- TMF/ISF maintenance
📌 Clinical Research Associate 2 - IQVIA Biotech (Barcelona)
🏢 Jobrapido
📍 Barcelona