Start-Up CRA for Cross-Therapy Trials

Regulatory Jobs; Nashville (TN); In loco; USD 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning and development opportunities

Descrizione del lavoro

ICON Strategic Solutions in Nashville, TN is seeking a Clinical Research Associate (Start-Up) to support cross-therapeutic trials and site activations in a sponsor-dedicated model. You will coordinate site qualification visits, manage regulatory documents, and ensure adherence to ICH-GCP and SOPs, while partnering with country operations to keep timelines and milestones on track.

Strong communication, independence, and data-driven problem solving are essential as you build relationships with

Competenze

• BS, RN, or equivalent in Biological Sciences or related field.
• Minimum 2–3 years’ experience monitoring pharma trials.
• Experience in cross-therapeutic area trials is preferred.
• Strong knowledge of ICH-GCP and regulatory requirements.

Mansioni

• Coordinate multi-trial start-up activities and site activation.
• Perform SQVs and select eligible sites per project timelines.
• Ensure regulatory documents and contracts are complete for activation.
• Maintain site relationships and communicate status to stakeholders.
• Monitor KPIs for site activation timelines and performance.

Conoscenze

Clinical Trial Monitoring

ICH-GCP knowledge

Regulatory compliance

Site activation

Formazione

BS, RN, or equivalent

Strumenti

CTMS

EDC

eTMF

IWRS

Descrizione del lavoro

ICON Strategic Solutions in Nashville, TN is seeking a Clinical Research Associate (Start-Up) to support cross-therapeutic trials and site activations in a sponsor-dedicated model. You will coordinate site qualification visits, manage regulatory documents, and ensure adherence to ICH-GCP and SOPs, while partnering with country operations to keep timelines and milestones on track.

Strong communication, independence, and data-driven problem solving are essential as you build relationships with