Remote Clinical Quality & Compliance Lead (EST)

WaveCrest Staffing Group; Connecticut; À distance; USD 90 000 - 96 000; Temps partiel

Avantages offerts par ce poste

Medical/dental coverage!

Weekly pay!

401k and PTO after 6 months!

Résumé du poste

Wavecrest Staffing Group is seeking a Clinical Quality & Compliance Lead for a fully remote, EST-hours role. You will guide clinical operations on regulatory compliance and quality across domestic and international trials, and support inspection readiness.

The role requires strong GCP/FDA/ICH knowledge and hands-on audit experience, with collaboration across QA, Regulatory Affairs, and legal teams. This 2-year contract emphasizes improved trial execution and regulatory adherence.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• Strong understanding of GCP, FDA regulations, and ICH guidelines.
• Experience in clinical research operations or quality assurance is essential.
• Hands-on involvement with audits and inspections is preferred.

Responsabilités

• Provide quality and compliance guidance to clinical operations supporting domestic and international trials.
• Evaluate processes to identify regulatory risks and opportunities for improvement.
• Support preparation for internal audits, site inspections, and regulator inspections.
• Partner with study teams to investigate compliance concerns and develop CAPAs.
• Monitor quality indicators and propose risk-reduction strategies.
• Develop and deliver targeted training to strengthen operations knowledge.
• Collaborate with QA, Regulatory Affairs, Legal and development teams to resolve quality concerns.
• Review processes to ensure alignment with regulatory requirements.
• Support process improvements to strengthen inspection readiness.

Connaissances

GCP knowledge

FDA regulations

ICH guidelines

Audits & inspections

Formation

Bachelor's degree in Life Sciences

Description du poste

Wavecrest Staffing Group is seeking a Clinical Quality & Compliance Lead for a fully remote, EST-hours role. You will guide clinical operations on regulatory compliance and quality across domestic and international trials, and support inspection readiness.

The role requires strong GCP/FDA/ICH knowledge and hands-on audit experience, with collaboration across QA, Regulatory Affairs, and legal teams. This 2-year contract emphasizes improved trial execution and regulatory adherence.