Clinical Research Associate (CRA) - Biotech

About the role

IQVIA Biotech supports innovators in clinical development and is looking for a CRA in Prague. In this highly organized model, you will join a project from its early stages and follow it through its full lifecycle, performing monitoring and site management so that sites run studies and report data as required by the protocol, regulations and sponsor requirements.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and regulatory requirements.
• Work with sites to adapt, drive and track the subject recruitment plan to make it predictable.
• Administer protocol and study training, keep regular contact with sites and manage ongoing expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues and track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept according to GCP and local regulations.
• Create and maintain documentation on site management, monitoring findings and action plans, including visit reports and follow-up letters.
• Liaise with study team members; may support the start-up phase, develop site-level recruitment plans, and handle site financial management and invoice retrieval where applicable.

Required profile

• Bachelor's degree; a degree in a scientific discipline or health care is preferred.
• At least 1 year of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements and good therapeutic and protocol knowledge gained through company training.
• IT literate, with written and verbal communication skills and a good command of English.
• Organizational, problem-solving, time and financial management skills, and ability to build effective working relationships with coworkers, managers and clients.