Senior CRA: Site Monitoring & Study Leadership

RBW Consulting; United States; On-site; USD 130,000 - 150,000; Full time

Job summary

RBW Consulting seeks a Senior CRA for the United States to oversee on-site monitoring from site initiation through close-out. You will ensure patient safety, regulatory compliance, data integrity, and trial documentation across multiple sites within PST/MST/CST zones.

You will mentor CRAs, support study team training, and may supervise other staff. Travel to sites is expected as part of duties. This role reports to the Senior Director of Monitoring in the US.

Qualifications

• Minimum 4 years of on-site clinical monitoring experience.
• Experience with GCPs and regulatory requirements.
• Familiarity with TMF processes and CRF/data review.

Responsibilities

• Identify and qualify investigative sites and prepare site qualification reports.
• Conduct site initiation visits and train site personnel on requirements.
• Perform site monitoring visits, reports, and issue resolution.
• Review source documents for accuracy and regulatory compliance.
• Assist with ethics submissions and regulatory approvals as needed.
• Manage site payment processes, budgets, and contracting as requested.
• Ensure training is documented and deviations are tracked.
• Coordinate data transmission and query resolution with data management.
• Oversee CRA work on assigned projects and provide feedback.

Skills

Clinical monitoring

GCP compliance

Regulatory knowledge

Data integrity

Site qualification

Site initiation

Training & mentorship

Team supervision

TMF management

Data management liaison

Job description

RBW Consulting seeks a Senior CRA for the United States to oversee on-site monitoring from site initiation through close-out. You will ensure patient safety, regulatory compliance, data integrity, and trial documentation across multiple sites within PST/MST/CST zones.

You will mentor CRAs, support study team training, and may supervise other staff. Travel to sites is expected as part of duties. This role reports to the Senior Director of Monitoring in the US.