Clinical Research Associate - Sponsor Dedicated
About the role
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.
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.
Pay
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.