Clinical Research Associate, Sponsor Dedicated

Clinical Research Associate, Sponsor Dedicated Denver, United States of America | Full time | Field-based | R1541733 To be eligible for this position, you must reside in the same country where the job is located. Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. 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. Escalate 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 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. If applicable, support development of project subject recruitment plan on a per site basis. If applicable, manage site financial matters according to the executed clinical trial agreement and retrieve invoices according to local requirements. Qualifications Bachelor's Degree in a scientific discipline or healthcare (preferred). Equivalent combination of education, training and experience may be accepted. At least 2 years of on-site monitoring experience. Good knowledge of and skill in applying clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Good therapeutic and protocol knowledge as provided in company training. Strong computer skills, including proficiency in Microsoft Word, Excel and PowerPoint and the use of a laptop, iPhone and iPad (where applicable). Excellent written and verbal communication skills, with good command of the English language. Strong 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 also be offered, in addition to a range of health and welfare and/or other benefits. 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, status as a protected veteran, or any other status protected by applicable law. 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. #J-18808-Ljbffr