QA and Compliance Manager (Clinical Research)

TL;DR

QA and Compliance Manager (Clinical Research): Ensuring regulatory compliance and quality management for clinical studies with an accent on ICH/GCP standards, FDA inspections, and internal SOP implementation. Focus on conducting audits, managing adverse event reporting, and leading investigations to maintain operational excellence across clinical trial activities.

Location: Must be based in the United States. Position is remote with 20% travel required to clinical sites.

Company

A clinical research organization dedicated to bringing innovative treatments to patients and improving community health through a people-first, collaborative approach.

What you will do

• Implement and maintain quality assurance policies and procedures.
• Conduct regular audits of clinical trial activities to ensure regulatory compliance.
• Oversee adverse event reporting and compliance documentation.
• Manage and implement Standard Operating Procedures (SOPs) for operational efficiency.
• Train staff on quality assurance practices and regulatory requirements.
• Lead investigations into quality deviations and develop corrective action plans.

Requirements

• Must be based in the United States.
• Bachelor's degree in a related field or equivalent experience.
• 2+ years of experience in clinical research quality and compliance roles.
• Subject matter expertise in ICH/GCP, FDA regulations, and HIPAA policies.
• Proven experience supporting FDA inspections and sponsor audits.
• Ability to travel to clinical sites up to 20% of the time.

Nice to have

• Experience supporting a multi-site clinical research network.

Culture & Benefits

• Supportive, values-driven work environment focused on integrity and results.
• Opportunity to make a direct impact on patient health and clinical outcomes.
• Collaborative team culture emphasizing professional growth and development.