CRA II / Sr. CRA – Multi-Therapy Site Monitoring Lead

IQVIA; Tampa (FL); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking Clinical Research Associates II (CRA II) and Senior Clinical Research Associates (Sr. CRA) to support multiple therapeutic areas across nationwide studies.

The role focuses on overseeing clinical trial sites to ensure adherence to protocols, GCP, ICH guidelines, and sponsor expectations. Responsibilities include site monitoring, performance evaluation, patient recruitment strategies, training, documentation in TMF/ISF, and cross-functional collaboration to meet milestones.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field preferred.
• 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.

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 elevate 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.

Skills

On-site monitoring

Communication skills

Regulatory understanding

Project coordination

MS Office proficiency

Education

Bachelor’s degree in Life Sciences or related field

Tools

Microsoft Office

Mobile/Electronic data capture

Job description

IQVIA is seeking Clinical Research Associates II (CRA II) and Senior Clinical Research Associates (Sr. CRA) to support multiple therapeutic areas across nationwide studies.

The role focuses on overseeing clinical trial sites to ensure adherence to protocols, GCP, ICH guidelines, and sponsor expectations. Responsibilities include site monitoring, performance evaluation, patient recruitment strategies, training, documentation in TMF/ISF, and cross-functional collaboration to meet milestones.