Job Description

Locations

• United States of America, New Jersey, Parsippany
• United States of America, KS, Overland Park
• United States of America, North Carolina, Durham
• United States of America, FL, Tampa
• United States of America, UT, Salt Lake City

Skills Required

• therapeutic areasintermediate
• Microsoft Office applicationsintermediate

Required Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field preferred. Relevant education and professional experience may be considered in lieu of a degree. (experience)
• Minimum of 2 years of independent on-site monitoring experience within the pharmaceutical, biotechnology, or CRO industry. (experience, 2 years)
• Strong understanding of clinical research processes and regulatory requirements, including GCP and ICH guidelines. (experience)
• Knowledge of therapeutic areas and clinical trial protocols gained through industry experience and training. (experience)
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, as well as mobile and electronic data capture technologies. (experience)
• Excellent verbal and written communication skills with the ability to effectively interact with investigators, site personnel, sponsors, and internal stakeholders. (experience)
• Strong organizational, problem-solving, and time management skills with the ability to manage multiple priorities in a fast-paced environment. (experience)
• Demonstrated ability to work independently while maintaining strong collaborative relationships with colleagues, clients, and study teams. (experience)
• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field preferred. Relevant education and professional experience may be considered in lieu of a degree. (experience)
• Minimum of 2 years of independent on-site monitoring experience within the pharmaceutical, biotechnology, or CRO industry. (experience, 2 years)
• Strong understanding of clinical research processes and regulatory requirements, including GCP and ICH guidelines. (experience)
• Knowledge of therapeutic areas and clinical trial protocols gained through industry experience and training. (experience)
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, as well as mobile and electronic data capture technologies. (experience)
• Excellent verbal and written communication skills with the ability to effectively interact with investigators, site personnel, sponsors, and internal stakeholders. (experience)
• Strong organizational, problem-solving, and time management skills with the ability to manage multiple priorities in a fast-paced environment. (experience)
• Demonstrated ability to work independently while maintaining strong collaborative relationships with colleagues, clients, and study teams. (experience)
• Join IQVIA and contribute to groundbreaking research while advancing your career with a global leader in healthcare and clinical development. Qualified candidates with experience across a variety of therapeutic areas are encouraged to apply. (experience)
• 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 (experience)
• 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. (experience)

Responsibilities

• Conduct all phases of site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits.
• Evaluate site performance and ensure adherence to study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Partner with investigative sites to develop, implement, and track patient recruitment and retention strategies that support enrollment goals.
• Deliver protocol-specific training and maintain ongoing communication with site staff to ensure alignment on study expectations and timelines.
• Identify, document, and escalate quality or compliance concerns while supporting timely resolution of issues.
• Monitor study progress by tracking regulatory submissions, approvals, enrollment metrics, CRF completion, and data query resolution.
• Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
• Prepare comprehensive monitoring reports, follow-up letters, and other required study documentation in accordance with company and sponsor standards.
• Collaborate cross-functionally with project teams to support study execution and achievement of project milestones.
• May participate in study start-up activities, site budget tracking, financial management, and site payment processes, depending on assignment.
• Conduct all phases of site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits.
• Evaluate site performance and ensure adherence to study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Partner with investigative sites to develop, implement, and track patient recruitment and retention strategies that support enrollment goals.
• Deliver protocol-specific training and maintain ongoing communication with site staff to ensure alignment on study expectations and timelines.
• Identify, document, and escalate quality or compliance concerns while supporting timely resolution of issues.
• Monitor study progress by tracking regulatory submissions, approvals, enrollment metrics, CRF completion, and data query resolution.
• Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
• Prepare comprehensive monitoring reports, follow-up letters, and other required study documentation in accordance with company and sponsor standards.
• Collaborate cross-functionally with project teams to support study execution and achievement of project milestones.
• May participate in study start-up activities, site budget tracking, financial management, and site payment processes, depending on assignment.

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