Clinical Research Associate 2 - Biotech

About the role

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. It is hiring a Clinical Research Associate 2 in Spain, a home-based position. The ideal candidate has varied therapeutic experience and is willing to work across multiple therapeutics such as oncology, hematology and cardiovascular.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and GCP and ICH guidelines
• Work with sites to adapt, drive and track the subject recruitment plan so it matches project needs
• Administer protocol and study training to assigned sites and keep regular contact to manage project expectations and issues
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support the start-up phase
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is maintained according to GCP and local regulations
• Create and maintain documentation on site management, monitoring visit findings and action plans, including visit reports and follow-up letters
• Liaise with study team members; may support the development of a site-level recruitment plan and, where applicable, site financial management and invoice retrieval

Required profile

• Bachelor's degree in a scientific discipline or health care preferred
• At least 1.5 years of on-site monitoring experience; equivalent education, training and experience may be accepted
• Organizational, time management and problem-solving skills
• Ability to build effective working relationships with coworkers, managers and clients
• Flexibility to travel and a driver's license