GCP QA Consultant / GCP QA Consultantess

GCP QA Consultant - Contract - Remote, USA

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 excel in a collaborative, fast-paced environment, this opportunity is for you. This is a fully remote role based in the US.

Primary Responsibilities

• Ensure compliance with Good Clinical Practice (GCP) standards.
• Drive quality improvements across clinical trials.
• Prepare for regulatory inspections and oversight.

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.

Key Responsibilities of the GCP QA Consultant

• 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.

If you are interested in this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter, dedicated to finding exceptional talent and matching them with top positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.