GCP QA Consultant

Proclinical Consulting; Boston (KY); À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GCP knowledge

CAPA implementation

RBQM understanding

Regulatory inspections

Root cause analysis

Communication skills

Organizational skills

Formation

Bachelor's degree in a scientific field

Advanced degree in clinical research

Description du poste

- Contract - Remote, US

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.

Primary Responsibilities

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

Skills & Requirements

• 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.

The GCP QA Consultant's Responsibilities Will Be

• 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.