Clinical Research Associate (CRA 2 / Sr CRA 1) - Sponsor Dedicated

About the role

iQVIA is looking for a Clinical Research Associate (CRA 2 / Senior CRA 1) based in Hungary to perform monitoring and site management work for a sponsor-dedicated clinical study. The role ensures that sites carry out the study and report study data as required by the protocol, applicable regulations and guidelines, and sponsor requirements.

Key responsibilities

• Perform site monitoring visits, covering selection, initiation, monitoring and close-out visits.
• Work with sites to adapt, drive and track the subject recruitment plan in line with project needs.
• Administer protocol and related study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate, and track regulatory submissions and approvals, recruitment, enrollment, CRF completion and submission, and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is maintained in line with GCP / ICH and local regulations.
• Create and maintain documentation such as visit reports, follow-up letters and other study documents.
• Liaise with study team members; may also support site-level recruitment planning and site financial management and invoice retrieval where applicable.

Required profile

• Bachelor's degree, preferably in a scientific discipline or health care.
• More than 1 year of on-site monitoring experience.
• Located in Hungary.

Required skills

• Good therapeutic and protocol knowledge.
• IT literate.
• Written and verbal communication skills, including English and Hungarian.
• Organizational, problem-solving, time and financial management skills.
• Ability to build effective working relationships with coworkers, managers and clients.