In-house Clinical Research Associate II - Oncology

Worldwide Clinical Trials; Charlotte (NC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Oncology trial experience

Site coordination

Data quality monitoring

Mentoring junior staff

Ausbildung

Bachelor's degree in life sciences / health sciences

Tools

IVRS

eCRF systems

Microsoft Office

Jobbeschreibung

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

• 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

Requirements

• Bachelor's degree in 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