Clinical Research Associate - SOAR

ICON Strategic Solutions; Nashville (TN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme (

Job summary

ICON Strategic Solutions is seeking a Clinical Research Associate (Start-Up) in Nashville, TN. You will support multiple trials in the Cross Therapeutic area, coordinating with country operations to activate sites and ensure adherence to ICH-GCP, SOPs, and regulatory requirements.

You’ll maintain site relationships, perform SQVs, manage contracts and essential documents, and provide regular updates to stakeholders while monitoring start-up KPIs.

Qualifications

• Requires a B.S., RN, or equivalent degree.
• Minimum 2–3 years’ experience monitoring pharmaceutical industry clinical trials.
• 1–3 years’ experience monitoring cross-therapeutic area trials.
• Analytical/risk-based monitoring experience is an asset.
• Ability to drive patient recruitment strategies and collaborate with site staff.
• Familiarity with GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Work on multiple trials within Cross Therapeutic areas with start-up focus.
• Collaborate with country operations to activate sites within project timelines.
• Perform Site Qualification Visits (SQVs) to assess site eligibility.
• Build relationships with site personnel to enable smooth onboarding.
• Ensure activities adhere to ICH-GCP, regulatory standards, and SOPs.
• Coordinate with country operations to collect regulatory documents and contracts.
• Serve as main point of contact for sites and study teams during start-up.
• Manage investigator contracts, regulatory documents, and start-up activities.
• Provide status updates to stakeholders and monitor KPIs for site activation.
• Identify and address issues delaying study initiation or deliverables.
• Maintain documentation for inspections readiness.
• Support site activation until Green Light status.

Skills

Site monitoring

Cross-therapeutic monitoring

Regulatory knowledge

Patient recruitment strategies

Communication & collaboration

GCP/ICH knowledge

Education

B.S. or RN or equivalent

Tools

CTMS

EDC

eTMF

IWRS

Job description

Clinical Research Associate (Start-Up) - Cross Therapeutic Area - Nashville, TN

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 Nashville, TN ; near a major airport. TN/KY near major hub acceptable.
• Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
• Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
• 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.

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