CRA 2, Oncology, IQVIA

Requirements

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs
• Administer protocol and related study training to assigned sites and establish regular lines of communication
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• 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
• 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
• 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
• Collaborate and liaise with study team members for project execution support as appropriate
• Support development of project subject recruitment plan on a per site basis
• Accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Benefits

• 401k Matching
• Tuition Reimbursement