Clinical Quality & Compliance Lead

WaveCrest Staffing Group; Connecticut; Remote; USD 90,000 - 96,000; Part time

Benefits offered by this job

Medical/dental coverage!

Weekly pay!

401k and PTO after 6 months!

Job summary

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.

Responsibilities

• 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.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Audits & inspections

Education

Bachelor's degree in Life Sciences

Job description

At this time, Wavecrest cannot transfer nor sponsor a work Visa for this position.

This fully remote position offers the opportunity to leverage extensive clinical research experience in a broader quality and compliance leadership capacity. You'll work with cross-functional clinical teams, contribute to inspection readiness initiatives, and help drive meaningful improvements in clinical trial execution and regulatory compliance.

Pay

$65.50-$70/hr

Schedule

M-F 1st shift

Type of Job

2-year contract

Location

Remote (must operate on EST hours)

Benefits Offered:

• Medical/dental coverage!
• Weekly pay!
• 401k and PTO after 6 months!

Clinical Quality & Compliance Lead Daily Tasks: What you will do:

• Provide quality and compliance guidance to clinical operations teams supporting domestic and international clinical trials.
• Evaluate clinical trial processes to identify regulatory risks, operational deficiencies, and opportunities for improvement.
• Support preparation for internal audits, investigator site inspections, and regulatory agency inspections.
• Partner with clinical study teams to investigate compliance concerns, determine root causes, and develop corrective and preventive action plans.
• Monitor quality indicators, recognize recurring compliance issues, and recommend risk-reduction strategies.
• Develop and facilitate targeted training programs to strengthen clinical operations knowledge and performance.
• Collaborate with Quality Assurance, Regulatory Affairs, Legal, and clinical development stakeholders to resolve complex quality concerns.
• Assist with reviewing clinical processes and documentation to ensure alignment with applicable regulatory requirements.
• Support process improvement projects that strengthen consistency, accountability, and inspection readiness.

Clinical Quality & Compliance Lead Qualifications/Requirements:

• Bachelor's degree, preferably in Life Sciences or a related scientific discipline.
• Extensive professional experience in clinical research, clinical operations, clinical development, or clinical quality assurance.
• Previous experience in a Clinical Trial Manager, Lead CRA, Clinical Quality, or comparable senior clinical operations role.
• Strong understanding of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and clinical research compliance requirements.
• Hands-on involvement with clinical trial audits, regulatory inspections, inspection preparation, or compliance investigations.

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!