GCP QA Consultant

Are you a GCP quality expert who thrives on ensuring clinical trial excellence and regulatory readiness in cutting-edge oncology research?

Proclinical is seeking a detail-oriented GCP QA Consultant to support clinical programs and trials in the oncology and biotechnology space. If you are passionate about advancing oncology treatments and thrive in a collaborative, fast-paced environment, this opportunity is for you.

This is a fully remote role based in the US.

The successful candidate will role focuses on ensuring compliance with Good Clinical Practice (GCP) standards, driving quality improvements, and preparing for regulatory inspections.

• 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.
• Ability to conduct root cause analyses and implement corrective and preventive actions (CAPAs).
• Familiarity with regulatory inspection processes and risk-based quality management.
• Excellent communication, problem-solving, and organizational skills.
• Certification as a Registered Quality Assurance Professional (RQAP) in GCP is expected.

• Review key clinical trial documentation, including Clinical Protocols, Investigator Brochures, Informed Consent Forms, Trial Master Files, and submission documents.
• Lead assessments and investigations of quality issues, including root cause analysis, remediation, and timely resolution.
• Facilitate reviews of potential Serious Breach and Urgent Safety Measure assessments for assigned clinical programs.
• Coordinate GCP-GVP vendor audits, manage risk-based site selection, and ensure proper audit execution and closure.
• Oversee quality management with functional lines and vendors, including leading Quality Oversight Committee meetings.
• Collaborate on implementing risk-based quality management (RBQM) strategies for specific studies, including critical data identification and reporting.
• Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis, strategy development, and program management.
• Provide guidance and training on compliance issues, leveraging expertise in GCP and industry best practices.
• Support the development, implementation, and maintenance of GCP SOPs as a Quality reviewer.