Clinical Trials Compliance Officer (Part Time)

Company Overview

The Bronchiectasis and NTM Association is dedicated to improving the lives of people affected by bronchiectasis and NTM lung disease. The Association is committed to advancing high-quality, specialized care, research, education, support, and advocacy within the bronchiectasis and NTM lung disease communities, helping people live longer, healthier lives.

The COPD Foundation is a leading, mission-driven organization dedicated to advancing the understanding, treatment, and management of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, and NTM lung disease. Our mission is to help millions of people live longer, healthier lives by accelerating research, expanding advocacy, and increasing awareness. We foster a collaborative and innovative environment where experts work together to develop meaningful solutions that improve outcomes for patients worldwide.

Position Overview

The Bronchiectasis and NTM Association is seeking a Clinical Trials Compliance Officer to provide clinical research compliance and quality oversight across the Association's growing research portfolio. Reporting to the Vice President of Operations, the Clinical Trials Compliance Officer will serve as a subject matter expert in clinical trial compliance, providing both strategic oversight and hands-on support across industry-sponsored, investigator-initiated, and real-world evidence studies. This role will help ensure research activities are conducted in accordance with applicable FDA regulations, Good Clinical Practice (GCP), organizational policies, sponsor requirements, and ethical standards. This is a part-time position averaging approximately 20 hours per week. Hours may fluctuate based on organizational and study needs, and the individual will need to be available during regular business hours for meetings as needed.

Key Responsibilities

• Provide compliance oversight and guidance throughout the clinical trial lifecycle, including study startup, conduct, monitoring, closeout, and audit or inspection readiness.
• Monitor compliance with applicable FDA regulations, ICH Good Clinical Practice (GCP), human subjects protection requirements, sponsor requirements, and organizational policies.
• Serve as a compliance resource to research staff, medical and scientific leadership, study sites, sponsors, and external vendors.
• Develop, review, and maintain clinical research SOPs, policies, work instructions, and study-specific compliance requirements.
• Maintain and continuously improve the Association's Quality Management System (QMS) and support risk-based quality management activities across clinical studies.
• Evaluate protocol deviations and compliance concerns and assist with appropriate documentation, corrective actions, and follow-up.
• Monitor and support Corrective and Preventive Action (CAPA