CRA 2, Oncology, Full Service, IQVIA

CRA 2 Position at IQVIA

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience. Essential functions include performing site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. The role involves working with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. The CRA 2 will administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. The role also includes evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. The CRA 2 will manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. They may support the start-up phase and ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. The CRA 2 will create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. They will collaborate and liaise with study team members for project execution support as appropriate. If applicable, the CRA 2 may be accountable for supporting development of project subject recruitment plan on a per site basis and may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Education: Bachelor's Degree (degree in scientific discipline or health care preferred)

Experience: 1.5 to 2 years of relevant CRA experience including on-site monitoring.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

EEO Minorities/Females/Protected Veterans/Disabled