Clinical Trial Monitoring Specialist

IQVIA; Florida; On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate (CRA) to perform on-site monitoring visits, ensure protocol compliance, and manage regulatory submissions across multiple US sites. You will drive patient recruitment plans, support site training, and maintain high-quality study documentation while collaborating with study teams to ensure timely, accurate data delivery.

The role requires strong communication, organizational, and problem-solving skills, with travel to sites as needed and a focus on

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of independent on-site monitoring experience as a CRA.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including Word, Excel and PowerPoint; use of laptop and mobile devices.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS and other trial systems.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills; time and financial management.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work.
• Drive subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol-related training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data query resolution.
• Ensure site documents are filed in the TMF and ISF maintained per requirements.
• Create and maintain documentation of site management, visit findings and action plans.
• Collaborate with study team members for project execution support.
• May support development of site recruitment plans and financial management where applicable.

Skills

Communication skills

Organizational skills

Time management

English proficiency

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate (CRA) to perform on-site monitoring visits, ensure protocol compliance, and manage regulatory submissions across multiple US sites. You will drive patient recruitment plans, support site training, and maintain high-quality study documentation while collaborating with study teams to ensure timely, accurate data delivery.

The role requires strong communication, organizational, and problem-solving skills, with travel to sites as needed and a focus on