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 Barcelona, Spain, on a home-based basis. 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 that 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 and ensure site documents are available for the Trial Master File and the Investigator's Site File is kept in line with GCP and local regulations
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support the start-up phase
• 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 under the clinical trial agreement

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