Senior Clinical Research Associate

Job DescriptionIQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:\n\nEssential Functions\nPerform 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.\n\nWork with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.\n\nAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.\n\nEvaluate 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.\n\nManage 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. May support start-up phase.\n\nEnsure 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.\n\nCreate 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.\nCollaborate and liaise with study team members for project execution support as appropriate.\n\nIf applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.\n\nIf applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.\n\nEducation: Bachelor’s Degree (Degree in scientific discipline or health care preferred)\n\nExperience: 1.5 to 2 years of relevant CRA experience including on-site monitoring.\n\nIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.\nThe potential base pay range for this role, when annualized, is $90,200.00 - $150,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.