Monitor and manage clinical study sites, ensuring regulatory compliance and adherence to study protocols. Facilitate communication and resolve issues to support site performance.
To be eligible for this position, you must reside in the same country where the job is located.
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 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 (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.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• 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.
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 (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.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• 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.
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, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
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.
The potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. 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.Top Skills
Excel
Ipad
Iphone
Microsoft Word
PowerPoint
Similar Jobs
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
As a Full Stack Software Engineer, you will develop tools for cloud management, build APIs and UIs, and maintain cloud systems.
Top Skills:
AWSCi/CdCloudFormationGoGrpcJavaScriptKubernetesLinuxReactRestful ApisTerraformTypescript
Legal Tech • Software • Generative AI
Lead a team of Account Executives in the Mid-Market segment, focusing on driving performance, scaling sales processes, and talent development.
Top Skills:
Ai PlatformB2B Saas
Big Data • Cloud • Information Technology • Software • Database • Analytics • Big Data Analytics
The Manager, Enterprise Campaigns & ABM will design and execute programs to accelerate pipeline in the enterprise segment, coordinate campaigns across teams, and lead ABM initiatives for existing customers.
Top Skills:
AICloudData AnalyticsProject Management Tools
What you need to know about the Colorado Tech Scene
With a business-friendly climate and research universities like CU Boulder and Colorado State, Colorado has made a name for itself as a startup ecosystem. The state boasts a skilled workforce and high quality of life thanks to its affordable housing, vibrant cultural scene and unparalleled opportunities for outdoor recreation. Colorado is also home to the National Renewable Energy Laboratory, helping cement its status as a hub for renewable energy innovation.
Key Facts About Colorado Tech
- Number of Tech Workers: 260,000; 8.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lockheed Martin, Century Link, Comcast, BAE Systems, Level 3
- Key Industries: Software, artificial intelligence, aerospace, e-commerce, fintech, healthtech
- Funding Landscape: $4.9 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Access Venture Partners, Ridgeline Ventures, Techstars, Blackhorn Ventures
- Research Centers and Universities: Colorado School of Mines, University of Colorado Boulder, University of Denver, Colorado State University, Mesa Laboratory, Space Science Institute, National Center for Atmospheric Research, National Renewable Energy Laboratory, Gottlieb Institute
