Oncology CRA II: Remote Mentorship & Site Oversight

Worldwide Clinical Trials; Charlotte (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Worldwide Clinical Trials seeks an experienced Clinical Research Associate II to manage oncology study sites in compliance with GCP standards and regulations. The role involves coordinating site activities, monitoring data quality, supporting field teams, and mentoring junior staff across virtual operations.

Responsibilities include overseeing TMF/ISF maintenance, conducting monitoring visits, reviewing EDC data for accuracy, coordinating materials, and supporting recruitment and staff changes

Qualifications

• Bachelor's degree in a medical, biological, physical, health, pharmacy, or related science.
• Minimum two years clinical research experience (study coordinator, research nurse, or equivalent).
• Demonstrated oncology clinical trial experience.
• Strong written and oral communication abilities.
• Proficiency with Microsoft Office and familiarity with IVRS and eCRF systems.
• Working knowledge of FDA/EU regulations, ICH Guidelines, and GCP principles.

Responsibilities

• Manage site documentation, TMF/ISF maintenance, and quality control per GDP standards.
• Conduct pre-study, initiation, interim, and closeout monitoring visits under CRA or CTM guidance.
• Review EDC data for completion and accuracy; assist sites in resolving queries and data issues.
• Coordinate study materials shipment, maintain site communication per monitoring plans.
• Mentor in-house CRA team members and support recruitment, prescreening, and site staff changes.

Skills

Oncology trial experience

Site coordination

Data quality monitoring

Mentoring junior staff

Education

Bachelor's degree in life sciences / health sciences

Tools

IVRS

eCRF systems

Microsoft Office

Job description

Worldwide Clinical Trials seeks an experienced Clinical Research Associate II to manage oncology study sites in compliance with GCP standards and regulations. The role involves coordinating site activities, monitoring data quality, supporting field teams, and mentoring junior staff across virtual operations.

Responsibilities include overseeing TMF/ISF maintenance, conducting monitoring visits, reviewing EDC data for accuracy, coordinating materials, and supporting recruitment and staff changes