Clinical Research Associate - SOAR

ICON plc; Bell (CA); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Dental & vision coverage

Retirement planning options

Employee assistance program

Job summary

ICON Strategic Solutions seeks a Clinical Research Associate (Start-Up) in the US to manage oncology trial site activation and start-up activities. You will work with country operations to qualify sites, coordinate regulatory documents, and maintain inspection-ready records.

You will ensure adherence to ICH-GCP and SOPs, build strong site relationships, and monitor KPIs to keep timelines on track.

Qualifications

• Minimum of a B.S., RN, or equivalent degree.
• 2–3 years’ experience monitoring pharmaceutical industry clinical trials.
• 1–3 years’ experience monitoring oncology clinical trials.
• Study Start-up experience required.
• Ability to operate and use systems/databases (CTMS, EDC, eTMF, IWRS, dashboards).
• Strong communication and influencing skills; able to work remotely and face to face.

Responsibilities

• Work on multiple trials within cross-therapeutic areas focusing on start-up.
• Collaborate with country operations teams to identify, select, and activate trial sites.
• Perform Site Qualification Visits to assess site eligibility for studies.
• Build strong relationships with site personnel to ease onboarding.
• Ensure activities adhere to ICH-GCP, local regulations, and SOPs.
• Coordinate with country operations to collect regulatory approvals and contracts for site activation.
• Serve as main contact for sites, study teams, and external stakeholders during start-up.
• Manage investigator contracts, regulatory documents, and start-up activities.
• Provide regular status updates to stakeholders and track start-up milestones.
• Monitor KPIs related to site selection and start-up timelines.
• Proactively address issues delaying study initiation or affecting deliverables.
• Maintain documentation for inspections readiness.
• Support activation until Green Light status is achieved.
• Coordinate pre-study requirements with site staff; assist in audits/inspections.

Skills

Clinical monitoring

Oncology trials

Study start-up

Communication

ICH-GCP knowledge

Education

Bachelor of Science or RN or equivalent

Tools

CTMS

EDC

eTMF

Dashboards

IWRS

Safety reporting

Job description

Clinical Research Associate (Start-Up) - Oncology - US

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.

What will you be doing?

• Works on multiple trials within the Cross Therapeutic areas - Start up focus
• Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
• Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
• Build strong relationships with site personnel to facilitate a smooth onboarding process.
• Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
• Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
• Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
• Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
• Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
• Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
• Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
• Maintain precise documentation to ensure readiness for inspections.
• Support sites during the activation phase until they achieve “Green Light” status for site opening.
• Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
• Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.

What do you need to have?

• Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
• Preferred location is near a major airport.
• Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
• Have a minimum of 1-3years' experience monitoring oncology clinical trials
• Study Start up experience required
• Analytical/risk-based monitoring experience is an asset
• Ability to actively drive patient recruitment strategies at assigned sites
• Ability to partner closely with investigator and site staff to meet all of our study timelines
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here