Sponsor-Centric Clinical Research Associate (On-site)

IQVIA; Saint Petersburg (FL); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to monitor trial sites, ensure protocol compliance, and maintain regulatory documentation in the United States. You will manage site communications, track enrollment, data queries, and TMF/ISF filing while collaborating with cross-functional teams to support trial delivery.

The role requires on-site monitoring experience, GCP/ICH knowledge, and strong English communication.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficient in Microsoft Word, Excel and PowerPoint; comfortable with laptop/iPad use.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.
• Strong written and spoken English communication skills.
• Excellent organizational, problem-solving and time-management abilities.
• Ability to build effective relationships with coworkers, managers, and clients.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to drive subject recruitment plans.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, enrollment, CRF completion, and data queries; support start-up as needed.
• Ensure site documents are filed in TMF and ISF maintained per regulatory requirements.
• Document site management activities and visit findings with reports and follow-ups.
• Coordinate with study team for project execution support.

Connaissances

Regulatory knowledge

Communication skills

Organizational skills

Problem solving

Time management

Financial management

Team collaboration

Formation

Bachelor's degree in scientific discipline or health care

Outils

Microsoft Word

Excel

PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Description du poste

IQVIA is seeking a Clinical Research Associate to monitor trial sites, ensure protocol compliance, and maintain regulatory documentation in the United States. You will manage site communications, track enrollment, data queries, and TMF/ISF filing while collaborating with cross-functional teams to support trial delivery.

The role requires on-site monitoring experience, GCP/ICH knowledge, and strong English communication.