Remote GCP QA Consultant – Oncology Regulatory Readiness

Proclinical Consulting; Boston (KY); Remote; USD 90,000 - 130,000; Full time

Job summary

Proclinical Consulting is seeking a remote US-based GCP QA Consultant to ensure clinical trial excellence and regulatory readiness in oncology programs. The role emphasizes GCP compliance, quality improvements, and inspections readiness across global sites.

The candidate should have strong GCP knowledge, CAPA experience, and familiarity with RBQM, with a bonus for EU exposure. A Registered QA professional certification is expected.

Qualifications

• Bachelor's degree in a scientific field; advanced degree in clinical research is a plus.
• Strong knowledge of GCP and clinical research practices in the US and EU; experience in other regions is a bonus.
• Experience in oncology clinical trials is preferred.

Responsibilities

• Review key clinical trial documentation, including Protocols, Investigator Brochures, ICFs, TMF, and submission documents.
• Lead assessments and investigations of quality issues, including root cause analysis and CAPA implementation.
• Coordinate GCP-GVP vendor audits and ensure audit completion and closure.
• Oversee quality management with vendors and leading Quality Oversight Committee meetings.
• Support RBQM strategy implementation and data reporting for studies.
• Lead pre-approval and routine regulatory inspection readiness activities and risk analyses.

Skills

GCP knowledge

CAPA implementation

RBQM understanding

Regulatory inspections

Root cause analysis

Communication skills

Organizational skills

Education

Bachelor's degree in a scientific field

Advanced degree in clinical research

Job description

Proclinical Consulting is seeking a remote US-based GCP QA Consultant to ensure clinical trial excellence and regulatory readiness in oncology programs. The role emphasizes GCP compliance, quality improvements, and inspections readiness across global sites.

The candidate should have strong GCP knowledge, CAPA experience, and familiarity with RBQM, with a bonus for EU exposure. A Registered QA professional certification is expected.