CRA II: Global Clinical Trials & Site Leadership

Emerald Clinical Trials Inc.; North Carolina; Ibrido; USD 110.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid or remote options

Global opportunities

Career growth opportunities

Employee wellbeing programs

Equal opportunity employer

Descrizione del lavoro

Emerald Clinical Trials Inc. seeks a Clinical Research Associate 2 (CRA2) to join the Clinical Operations team. You will manage sites, monitor trials per plan, and ensure regulatory compliance across regions.

The role emphasizes investigator training, TMF quality, and timely site payments. The ideal candidate has 2–5 years of on-site monitoring experience, a related science degree, and strong knowledge of ICH-GCP guidelines.

Competenze

• Qualifications in a related science or health care discipline.
• 2–5 years in on-site monitoring and site management in clinical trials.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience with project management and TMF processes.
• Excellent communication and collaboration across teams.

Mansioni

• Coordinate identification, feasibility, and selection of investigators and sites.
• Complete monitoring activities per Monitoring Plan and write visit reports.
• Plan and conduct site evaluation visits and report findings.
• Prepare regulatory packages and Ethics Committee updates.
• Negotiate site budgets and manage contracts and invoicing.
• Organize site initiation visits and monitor start-up progress.
• Maintain monitoring tools and trial documentation.
• Train investigators on protocol and trial requirements; manage TMF.
• Reconcile TMF contents and site files.
• Coordinate handling of investigational product and supplies.
• Maintain trial information in the CTMS and tracking tools.
• Support strategies to boost recruitment.

Conoscenze

Clinical monitoring

Site management

Negotiation

Communication

Problem solving

Travel flexibility

Team collaboration

Formazione

Science/Health care degree

Descrizione del lavoro

Emerald Clinical Trials Inc. seeks a Clinical Research Associate 2 (CRA2) to join the Clinical Operations team. You will manage sites, monitor trials per plan, and ensure regulatory compliance across regions.

The role emphasizes investigator training, TMF quality, and timely site payments. The ideal candidate has 2–5 years of on-site monitoring experience, a related science degree, and strong knowledge of ICH-GCP guidelines.