Rae Lynn DeFeo, BS, MBA, CCRP

Critical Care Division / Pulmonary Medicine: SoCRA-Certified Senior Clinical Research Coordinator II @ Baystate Health

About

Research SpecialistWith a career defined by clinical depth and technical precision, navigated some of the most complex and high-stakes domains in modern medicine. My expertise spans the full spectrum of patient care—from pediatric and adult hematology/oncology to the intricate demands of critical care and pulmonary medicine.This breadth of experience reflects a unique ability to adapt to diverse therapeutic environments, managing the delicate intersection of patient safety and scientific rigor.By coordinating research across these critical specialties, I have played a pivotal role in bringing life-saving therapies and innovative medical devices from the laboratory to the bedside. My background suggests a professional who is as comfortable with complex regulatory landscapes as they are with the clinical realities of diverse patient populations.

Country

United States

City

Springfield

Industry

Biotechnology

Skill

Internal Medicine, Customer Service, Informatics, Healthcare Management, Nursing, Public Health, Hospitals, Strategic Planning, Clinical Trials, Hematology, Clinical Research

Experience

Critical Care Division / Pulmonary Medicine: SoCRA-Certified Senior Clinical Research Coordinator II

Baystate Health

2021-5 - Present · 5 yrs 5 mos

Senior, results-driven SoCRA-certified Clinical Research Professional with 21 years of experience providing strategic leadership and operational oversight for pharmaceutical and NIH-funded clinical trials. Extensive background in managing site operations, independently supporting multiple physicians and leading cross functional teams of investigators, RNs and clinical research coordinators. Demonstrated expertise in driving regulatory compliance through proactive internal and external audit management and continuous process improvement initiatives. Proven ability to partner with sponsors and CROs to oversee study execution from site selection and start-up through close-out, ensuring timelines, quality, and budget expectations are met. Possesses comprehensive knowledge of ICH-GCP guidelines, strong command of local regulatory requirements, and advanced expertise in recruitment strategy, drug and device accountability, and regulatory documentation management.

Regional Site Manager, Nephrology Clinical Research along with Covid pharmaceutical trials.

DaVita Clinical Research, CRO

2017-10 - 2021-5 · 3 yrs 8 mos

Connecticut, United States

Senior Clinical Research Manager| SoCRA-CCRP Directed clinical trials operations for pharmaceutical trials. Expert in regulatory compliance, audit readiness, sponsor engagement, and operational excellence cross the full study life cycle. Provide strategic oversight of multi-study clinical research operations, independently supporting multiple physicians and leading cross-functional teams. Lead and mentor investigator, RNs, and research coordinators to drive protocol adherence, performance consistency, and regulatory compliance. Direct internal and external audits, proactively managing risk and implementing CAPA to maintain inspection-ready operations. Partner with sponsors and CROs to oversee studies from site selection and start-up through close-out, ensuring quality, timelines, and deliverables. Ensure full compliance with ICH-GCP guidelines and local regulatory documentation management. Oversee drug and device accountability, ensuring accurate documentation, reconciliation, and compliance. Implement process improvements that strengthen operational efficiency and research quality.

Senior Certified Clinical Research Coordinator II

Baystate Health

2014-11 - 2017-10 · 3 yrs

D'Amour Center for Cancer Care @ Baystate Medical Center

Radiation Trials: ( Brain, Pancreas, Breast, esophageal ) Surgical: Lung, Breast Therapeutic trials: Breast studies: Pharma, Government & internal trials