Senior CRA II — Remote/Hybrid, Global Trials

Emerald Clinical; United States; Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Hybrid or remote work

Global exposure

Career growth opportunities

Employee wellbeing programs

Job summary

Emerald Clinical Trials is seeking a Clinical Research Associate II (CRA2) to join the Clinical Operations team. The role focuses on site management, monitoring activities, and regulatory support across multiple trials in various phases, with emphasis on quality and regulatory compliance.

Responsibilities include site identification, feasibility assessment, budgeting, initiation visits, and TMF management. Travel is required; candidates should have 2–5 years of on-site monitoring experience and

Qualifications

• Qualifications in a related science or health care discipline.
• 2-5 years of on-site monitoring and site management experience mandatory.
• Demonstrate practical knowledge of ICH-GCP guidelines and regulatory requirements.
• Strong negotiation, conflict resolution, critical thinking and problem-solving skills.
• Excellent interpersonal communication and ability to work in a multi-disciplinary team.

Responsibilities

• Coordinate investigator/site feasibility and selection for the trial.
• Complete monitoring activities per the Monitoring Plan and reports on time.
• Plan and conduct site evaluation visits and report findings.
• Prepare regulatory packages and liaise on ethics, import/export requirements.
• Negotiate site budgets and track contract execution and payments.
• Organize site initiation visits and assign resources as needed.
• Maintain monitoring tools and project documents; ensure TMF quality.
• Train site personnel on protocol, product and trial requirements.

Skills

Negotiation

Critical thinking

Problem solving

Decision making

Strategic thinking

Interpersonal communication

Presentation skills

Travel readiness

Education

Related science or health care discipline

Job description

Emerald Clinical Trials is seeking a Clinical Research Associate II (CRA2) to join the Clinical Operations team. The role focuses on site management, monitoring activities, and regulatory support across multiple trials in various phases, with emphasis on quality and regulatory compliance.

Responsibilities include site identification, feasibility assessment, budgeting, initiation visits, and TMF management. Travel is required; candidates should have 2–5 years of on-site monitoring experience and