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Clinical Research Associate - Sponsor Dedicated

IQVIA
  • Parsippany, Kansas
    6 days ago

    Job Description

    Clinical Research Associate II & Senior Clinical Research Associate (CRA II/Sr. CRA)Multiple Therapeutic Areas | Nationwide Opportunities

    IQVIA is actively seeking experienced Clinical Research Associates II (CRA II) and Senior Clinical Research Associates (Sr. CRA) to support a range of clinical studies across multiple therapeutic areas nationwide. This is an exciting opportunity to join a global leader in clinical research and play a vital role in advancing innovative therapies that improve patient outcomes.

    In this role, you will be responsible for overseeing clinical trial sites to ensure studies are conducted in compliance with study protocols, regulatory requirements, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and sponsor expectations. Successful candidates will possess strong site management skills, a commitment to quality, and the ability to build productive relationships with investigators and site personnel.

    Key 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.

    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.

    • Minimum of 2 years of independent on-site monitoring experience within the pharmaceutical, biotechnology, or CRO industry.

    • Strong understanding of clinical research processes and regulatory requirements, including GCP and ICH guidelines.

    • Knowledge of therapeutic areas and clinical trial protocols gained through industry experience and training.

    • Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, as well as mobile and electronic data capture technologies.

    • Excellent verbal and written communication skills with the ability to effectively interact with investigators, site personnel, sponsors, and internal stakeholders.

    • Strong organizational, problem-solving, and time management skills with the ability to manage multiple priorities in a fast-paced environment.

    • Demonstrated ability to work independently while maintaining strong collaborative relationships with colleagues, clients, and study teams.

    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.

    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.

    Numbers & Facts

    LocationParsippany, Kansas
    IndustryHealthcare Services
    Company Size10,000 employees or more
    Year Founded1982
    Websitehttps://www.iqvia.com/

    About Company

    IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

    Skills

    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Managementunmatched
    • Case Report Form (CRF)unmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Contract Research Organization (CRO)unmatched
    • Cross-Functionalunmatched
    • Customer Relationsunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Electronic Data Capture (EDC)unmatched
    • Employee Retentionunmatched
    • Financial Managementunmatched
    • GCP (Good Clinical Practices)unmatched
    • Healthcareunmatched
    • ICH Regulationsunmatched
    • International Healthunmatched
    • Maintain Complianceunmatched
    • Medical Treatmentunmatched
    • Metricsunmatched
    • Microsoft Excelunmatched
    • Microsoft Officeunmatched
    • Microsoft PowerPointunmatched
    • Microsoft Wordunmatched
    • Multitaskingunmatched
    • Nursingunmatched
    • Organizational Skillsunmatched
    • Patient Careunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Recruiting Strategyunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Research Protocolsunmatched
    • Retention Programsunmatched
    • Site Evaluationunmatched
    • Startupunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Writing Skillsunmatched

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