Senior CRA - IQVIA Biotech
Join IQVIA Biotech - Where Innovation Meets Impact At IQVIA Biotech, we specialize in partnering with smaller biotech and emerging biopharma companies, creating a uniquely dynamic and fast-paced environment. Here, you won''t just be part of the process-you''ll be at the forefront of it. You''ll gain early insights into groundbreaking therapies and novel diseases, often before they reach the broader scientific community. If you''re passionate about innovation and eager to make a real difference in the world of biotech, this is your opportunity to thrive. Responsibilities • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and ..... full job details .....
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