CRA - Sponsor Aligned

IQVIA LLC; Overland Park (KS); On-site; USD 75,000 - 175,000; Full time

Job summary

IQVIA LLC is seeking a Clinical Monitoring professional in Overland Park, KS, to ensure sites conduct studies per protocol and regulations. You will monitor, train, and manage site activities, data quality, and regulatory submissions, with strong communication to sponsor teams.

The role requires 1+ year of on-site monitoring, GCP/ICH knowledge, and proficiency in Word/Excel/PowerPoint. Collaboration with study teams and effective time/financial management are essential.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Requires at least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• GCP and ICH guidelines knowledge required.
• Good therapeutic and protocol knowledge provided in company training.
• Proficient with Microsoft Word, Excel and PowerPoint; laptop and mobile use.
• Excellent written and verbal communication in English.
• Strong organizational and problem-solving abilities.
• Effective time and financial management skills.
• Ability to collaborate with study team and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out).
• Drive and track subject recruitment plans to improve predictability.
• Administer protocol training and maintain site communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain TMF and ISF documentation per GCP and local rules.
• Submit visit reports, follow-up letters, and other study documents.
• Collaborate with study team for project execution support.
• Support development of recruitment plans and site budgets where applicable.

Skills

On-site monitoring

GCP/ICH knowledge

Communication skills

Time management

Problem solving

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Word

Excel

PowerPoint

Job description

Job Overview

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 visits) in accordance with contracted scope of work and regulatory requirements, i.e., 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. 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 (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.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Salary and Benefits

The potential base pay range for this role, when annualized, is $74,500.00 - $175,100.00. 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.

Company Information

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

Equal Opportunity Employer

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. https://jobs.iqvia.com/eoe

Integrity Policy

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.

Diversity Statement

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Closing

Thank you for your interest in growing your career with us.