Description
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.
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.
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.
The potential base pay range for this role, when annualized, is $74,500.00 - $197,500.00.