Clinical Research Associate - SOAR

ICON Strategic Solutions provides sponsor-dedicated clinical research services supported by global expertise. The Clinical Research Associate (Start-Up) will support multiple cross-therapeutic clinical trials by identifying, qualifying, and activating sites, coordinating start-up documentation, and ensuring compliance with regulatory and project requirements.

Responsibilities

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

Benefits

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

Company

Outsourced clinical development and commercialization services for life sciences

Dublin , GB

https://www.iconplc.com/services/strategic-solutions/

10001+ employees

Qualifications

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

Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials

Required skills

Clinical Trial Monitoring, Cross-Therapeutic Area Clinical Trials, Risk-Based Monitoring, Patient Recruitment, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Interactive Web Response Systems (IWRS), Safety Reporting, Clinical Practice (GCP), ICH Guidelines, Local Regulatory Requirements

Experience

1-3 years