The Clinical Research Associate will conduct monitoring visits, ensure compliance with study protocols, manage site communications, and support regulatory submissions and study management.
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 $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.Similar Jobs
Healthtech • Biotech • Pharmaceutical
Conduct site qualification, initiation, monitoring, management, and close-out visits to ensure protocol, regulatory and ICH/GCP compliance. Review source documents and CRFs, manage queries, investigational product handling, ISF/TMF reconciliation, documentation, and support audit readiness. Act as liaison with sites and sponsors, support recruitment/retention, and may train junior staff. Heavy travel (up to 75%).
eCommerce • Healthtech • Kids + Family • Retail • Social Media
Own multi-state U.S. payroll for 600–1,000 employees across approximately 35 states, including payroll processing, audits, corrections, and employee support. Manage a comprehensive compliance calendar covering federal and state filings, screenings, training, policy updates, and employment-law changes. Design internal controls, maintain audit evidence, improve procedures, and build automation. Partner with People Operations, Accounting, Legal, outside counsel, and the payroll provider to ensure accurate, timely, and compliant payroll operations.
Top Skills:
AIChatgptClaudeEnterprise HrisPaylocityWorkflow Automation
Artificial Intelligence • Cloud • Sales • Security • Software • Cybersecurity • Data Privacy
Prepares quarterly and annual US GAAP tax accounting workpapers, supports federal and state tax compliance, calculates estimated tax payments, coordinates with tax providers, resolves tax notices and audits, researches global tax updates, and drives process improvement and automation using OneSource Tax Provision.
Top Skills:
Onesource Tax ProvisionUs Gaap
What you need to know about the Austin Tech Scene
Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.
Key Facts About Austin Tech
- Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
- Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
- Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
- Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center
