CRA II: Risk‑Based Monitoring & Site Leadership

Regulatory Jobs; North Carolina; On-site; USD 70,000 - 100,000; Full time

Job summary

Regulatory Jobs is seeking a CRA (Level II) to conduct and coordinate all aspects of clinical monitoring and site management, including remote or on-site visits to verify protocol and regulatory compliance. The role ensures audit readiness, documents observations, and maintains essential documents per ICH-GCP.

The position requires a life sciences degree or RN certification, 1 year of experience, and frequent travel (75%+). Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor’s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic qualification.
• 1 year of clinical research monitoring experience (comparable).
• Valid driver’s license where applicable.
• Equivalency may be considered with education, training and/or related experience.

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach.
• Applies RCA and problem-solving to identify site process failures and CAPAs.
• Ensures data accuracy through SDR, SDV and CRF review during on-site and remote monitoring.
• Assesses investigational product through inventory and records review.
• Documents observations in reports and letters; escalates issues to clinical management.
• Maintains regular contact with sites between visits to ensure protocol adherence and data capture.
• Performs trial close out and retrieves trial materials.
• Ensures essential documents are complete per ICH-GCP and regulations.
• Facilitates communication between sites, client and project team.
• Travel requirement >75%.

Skills

Clinical monitoring

Regulatory compliance

Problem solving

Documentation

Communication

Teamwork

Attention to detail

Time management

English proficiency

Education

Bachelor’s degree life sciences

Registered Nursing certification

Tools

Microsoft Office

Job description

Regulatory Jobs is seeking a CRA (Level II) to conduct and coordinate all aspects of clinical monitoring and site management, including remote or on-site visits to verify protocol and regulatory compliance. The role ensures audit readiness, documents observations, and maintains essential documents per ICH-GCP.

The position requires a life sciences degree or RN certification, 1 year of experience, and frequent travel (75%+). Strong communication and problem-solving skills are essential.