Lead Phase I Clinical Research Associate

Regulatory Jobs; United States; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Pension plans

Life insurance

Employee assistance

Training & development

Job summary

ICON Strategic Solutions is seeking a Senior Clinical Research Associate to monitor Phase I trials in a sponsor-dedicated model, upholding GCP and regulatory standards. You will oversee multiple sites and drive data integrity while collaborating with cross-functional teams.

The role requires a strong CRA background, travel up to 60%, and a commitment to training site staff and maintaining high trial conduct standards within ICON Plc's global framework.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience as a CRA with strong knowledge of trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with ability to influence and drive compliance.
• Willingness to travel as required (approximately 60%).

Responsibilities

• Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and GCP standards.
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution.
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting.
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Skills

Clinical trial monitoring

Site management

GCP compliance

Data integrity

Regulatory requirements

Cross-functional collaboration

Stakeholder communication

Education

Bachelor's degree (scientific/healthcare)

Tools

Clinical trial software

Data management tools

Job description

ICON Strategic Solutions is seeking a Senior Clinical Research Associate to monitor Phase I trials in a sponsor-dedicated model, upholding GCP and regulatory standards. You will oversee multiple sites and drive data integrity while collaborating with cross-functional teams.

The role requires a strong CRA background, travel up to 60%, and a commitment to training site staff and maintaining high trial conduct standards within ICON Plc's global framework.