Senior Clinical Research Associate or CRA 2

Join a team that advances clinical research

We are looking for a passionate and motivated Clinical Research Associate (CRA) to join our team and play a key role in conducting high-quality clinical trials. In this role, you will collaborate with investigator sites and cross-functional teams to ensure that studies are conducted with excellence, compliance, and patient-centricity.

Job Overview

Monitor and manage centers to ensure they conduct studies and produce study data reports in accordance with the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring, and closure visits) in accordance with the scope of work indicated in the contract and clinical best practices.
• Work with centers to adapt, drive, and track the subject recruitment plan in accordance with project needs to improve predictability.
• Administer the protocol and related study training in assigned centers and regularly communicate with centers to manage expectations and ongoing project issues.
• Assess the quality and integrity of study site practices related to the smooth conduct of the protocol and compliance with applicable regulations. Report quality issues, if any.
• Manage the progress of assigned studies by tracking submissions and regulatory approvals, recruitment and enrollment, completion and submission of the case report form (CRF), and production and resolution of data queries. Provide support during the startup phase, if needed.
• Ensure that copies/originals (as needed) of center documents are added to the master trial file (MTF) and verify that the investigator center file (ICF) is maintained in accordance with clinical best practices and local regulatory requirements.
• Create and maintain appropriate documentation regarding center management, monitoring visit results, and action plans by submitting regular monitoring reports, generating follow-up letters, and other required study documents.
• Collaborate and interface with study team members for project execution support, if applicable.
• If applicable, support the development of the project's subject recruitment plan for a given center.
• If applicable, oversee the financial management of the center in accordance with the signed clinical trial agreement and retrieve invoices in accordance with local requirements.

Education and Experience

• Bachelor's degree in a scientific discipline or health care required
• At least 2 years of on-site monitoring experience
• A combination of equivalent education, training, and experience may also be accepted
• Good knowledge and ability to apply applicable regulatory requirements in clinical research
• That is, clinical best practices (CBP) and International Council for Harmonisation (ICH) guidelines.

IQVIA is one of the world's leading providers of advanced analytics, technology solutions, and clinical research services for the life sciences industry. We believe it is essential to push the boundaries of human and data science to have the greatest possible impact and help our clients create a healthier world. Learn more at https://jobs.iqvia.com.

IQVIA 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 https://jobs.iqvia.com.

IQVIA 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, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at ... so that IQVIA can support your participation in the recruitment process.

IQVIA 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.

Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.

The potential base pay range for this role, when annualized, is $84,000.00 - $170,900.00. 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 wellness and/or other benefits.