CRA II: Site Monitoring & Compliance

Linical Co.,Ltd.; Florida; On-site; USD 95,000 - 120,000; Full time

Job summary

Linical Co.,Ltd. is seeking a Clinical Research Associate II (CRA II) to oversee feasibility, initiation, monitoring, and close-out of investigative sites in the United States, Florida.

The role ensures participant safety, site compliance with GCPs and regulations, and data integrity through source data verification and monitoring processes. CRAs report to the Senior Manager of Site Management and Monitoring.

Qualifications

• Strong knowledge of GCPs and regulations.
• Excellent written and verbal communication skills.
• Fluent in local language with English comprehension.
• Ability to work in a matrixed team environment.
• Travel up to 75%.
• Valid driver’s license.

Responsibilities

• Identify potential sites and prepare site qualification reports.
• Conduct site initiation visits and train site personnel on requirements.
• Perform site monitoring visits and ensure compliance with study plans and GCPs.
• Review source documents and CRFs for accuracy and completeness.
• Assist in regulatory submissions to ethics committees and authorities.
• Coordinate site payments, budgets and contracts.
• Maintain TMF filings and data transmission to data management.
• Attend team meetings and participate in User Acceptance Testing.
• Close-out visits including IP reconciliation and TMF retrieval.

Skills

Clinical trial process

GCP & regulatory knowledge

Data integrity

Study monitoring

Communication skills

Time management

Travel readiness

Driver's license

Education

Life Science degree

Nursing background

CRA training program

Tools

TMF software

Clinical trial data systems

Job description

Linical Co.,Ltd. is seeking a Clinical Research Associate II (CRA II) to oversee feasibility, initiation, monitoring, and close-out of investigative sites in the United States, Florida.

The role ensures participant safety, site compliance with GCPs and regulations, and data integrity through source data verification and monitoring processes. CRAs report to the Senior Manager of Site Management and Monitoring.