Clinical Research Associate - Sponsor Dedicated

Clinical Research Associate - Sponsor Dedicated Overland Park, United States of America | Full time | Field-based | R1543487 Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions Perform site monitoring visits (selection, initiation, monitoring, and close‑out) in accordance with contracted scope of work and regulatory requirements, e.g., 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; raise 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 data query generation and resolution; may support start‑up phase. Ensure copies/originals of required site documents are available for filing in the Trial Master File (TMF) and that the Investigator’s Site File (ISF) is maintained in accordance with GCP/ICH 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. When applicable, support development of project subject recruitment plan on a per‑site basis. When applicable, manage site financial matters according to the executed clinical trial agreement and retrieve invoices as required. Qualifications Bachelor’s degree in a scientific discipline or health care preferred. Equivalent combination of education, training, and experience may be accepted in lieu of a degree. Completion of CRA training program or prior monitoring experience may be required by some organizations. Basic knowledge of and skill in applying applicable clinical research regulatory requirements (e.g., GCP and ICH guidelines). Good therapeutic and protocol knowledge as provided in company training. Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint; experience with laptop, iPhone, and iPad when applicable. Strong written and verbal communication skills; good command of English. Organizational and problem‑solving skills. Effective time and financial management skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. 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. Equal Opportunity Statement IQVIA is a proud 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. #J-18808-Ljbffr