Senior Clinical Research Associate - Phase I ONC

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

Senior Clinical Research Associate - Phase I ONC

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

What You Will Do:

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical 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 the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.