CRA 1/2

IQVIA AG seeks a Mid-level CRA 1/2 for on-site work in Switzerland. The role focuses on site monitoring, regulatory compliance, and study management to ensure data integrity and protocol adherence.

This position is responsible for overseeing clinical trial sites to guarantee that studies are conducted and reported in strict accordance with the protocol, regulatory standards, and sponsor expectations. The incumbent ensures that sites maintain high-quality practices and deliver accurate data throughout the trial lifecycle.

Responsibilities

• Conduct all phases of site monitoring visits, including selection, initiation, routine monitoring, and close-out, adhering to the agreed scope and regulatory rules.
• Partner with sites to develop, adjust, and monitor subject recruitment strategies to improve enrollment predictability and meet project timelines.
• Provide protocol and study-specific training to assigned sites and maintain consistent communication channels.
• Assess the quality and integrity of site operations to verify compliance with the protocol and applicable regulations.
• Track study progress by monitoring regulatory submissions, recruitment rates, Case Report Form (CRF) completion, and the resolution of data queries.
• Ensure that site documentation is properly filed in the Trial Master File (TMF) and that the Investigator's Site File (ISF) is maintained according to Good Clinical Practice (GCP) standards.
• Document site management activities and monitoring findings by preparing regular visit reports and issuing follow-up letters as needed.
• Collaborate with study team members to support overall project execution.
• Assist in the creation of site-specific subject recruitment plans when applicable.
• Manage site financials in line with the executed clinical trial agreement and process invoices according to local requirements.

Requirements

• Bachelor's degree in a scientific or healthcare discipline is preferred.
• Minimum of one year of experience in on-site clinical monitoring.
• Strong understanding and practical application of clinical research regulations, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Solid knowledge of therapeutic areas and protocols, as developed through company training.
• Proficient written and verbal communication skills, with a good command of English.

Nice to have

• An equivalent combination of education, training, and professional experience may be considered in place of a formal degree.