Alexa Barrio
@alexabarrio
Experienced Senior Clinical Research Program Manager with proven leadership skills.
What I'm looking for
I am an experienced Senior Clinical Research Program Manager with over 5 years of expertise in clinical research. My background includes a strong focus on regulatory compliance, clinical trial management, and research coordination. I have a proven track record of leading clinical research teams and streamlining processes to enhance efficiency and accuracy in healthcare research environments.
At Northwell Health, I serve as the primary point of contact for clinical research sites, ensuring adherence to protocols and regulatory standards. My role involves conducting on-site and remote monitoring, leading site initiation and training sessions, and facilitating regulatory submissions. I am dedicated to fostering research quality and compliance through effective training and communication with professional staff.
My educational background includes a Master of Public Health from Adelphi University, which complements my practical experience in the field. I am passionate about advancing clinical research and contributing to the improvement of healthcare outcomes through rigorous research practices.
Experience
Work history, roles, and key accomplishments
Senior Clinical Research Program Manager, Regulatory
Northwell Health
Jan 2023 - Present (2 years 5 months)
Served as the primary contact for clinical research sites, handling inquiries on protocol conduct and regulatory documentation. Led site initiation and training sessions for study start-up activities, ensuring preparedness for audits and inspections. Developed and delivered training sessions to professional staff, fostering research conduct compliance and quality improvement.
Regulatory Coordinator
Northwell Health
Jan 2022 - Dec 2022 (11 months)
Managed and maintained the research database, tracking all research trials and ensuring timely submission of studies and supporting documents to the IRB. Collaborated with investigators to prepare protocol summaries and consent forms according to OHRP, FDA, and IRB standards. Acted as a liaison between the IRB and Cancer Institute investigators, facilitating communication and submitting progress r
Clinical Research Coordinator, Rheumatology
Northwell Health
Jan 2021 - Dec 2021 (11 months)
Ensured adherence to Good Clinical Practice (GCP) guidelines and compliance with regulatory and grant agency requirements. Managed the Investigator Site File (ISF) for multiple studies, collaborating with the IRB as necessary. Coordinated with CROs, sponsors, and healthcare providers to ensure the integrity and compliance of ongoing studies.
Clinical Research Assistant, Cardiology
Northwell Health
Jan 2020 - Dec 2020 (11 months)
Independently conducted studies, adhering to experimental protocols and maintaining compliance with regulatory standards. Recruited and retained study participants based on protocol inclusion and exclusion criteria. Participated in the design and writing of protocols, case report forms, and informed consent forms.
Ophthalmic Technician
MEETH
Jan 2019 - Dec 2019 (11 months)
Collaborated with Uveitis Specialists to provide care for auto-immune compromised patients, documenting medical histories and performing initial patient examinations. Conducted diagnostic tests, including visual acuity assessments and intraocular pressure checks, and maintained patient records using the Intellechart EMR system. Acted as a patient liaison, addressing concerns via email and facilita
Education
Degrees, certifications, and relevant coursework
Adelphi University
Master of Public Health, Public Health
Completed a Master of Public Health program. Focused on advanced studies in public health principles and practices. Gained expertise relevant to clinical research and healthcare management.
Queens College
Bachelor of Arts, Arts
Obtained a Bachelor of Arts degree. Developed foundational knowledge and critical thinking skills. Prepared for further academic pursuits and professional roles.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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