Open to opportunities

Delayna Willie

@delaynawillie

Clinical research coordinator with neurology trial experience, regulatory compliance expertise, and strong patient-facing skills.

United States

Message

What I'm looking for

I seek a pharmaceutical or clinical operations role where I can leverage site experience, regulatory knowledge, and patient-facing skills to support trial execution and improve study outcomes.

I am a Clinical Research Coordinator with a Master of Science in Biomedical Sciences and hands-on experience coordinating multi-center neurology trials at Johns Hopkins University. I lead study start-up, recruitment, informed consent, and site-level execution while ensuring compliance with GCP, ICH, and FDA regulations.

I have proficiency with EDC and EMR platforms including Medidata, REDCap, Florence, EPIC, OnCore, and eClinicalWorks, and am certified in ALS Functional Rating Scale, spirometry, phlebotomy, and ECGs. I maintain data integrity, resolve discrepancies per sponsor timelines, and manage IRB submissions and regulatory documentation to support audit readiness.

I bring published research experience in developmental biology, strong cross-functional collaboration skills, and a track record of improving operational workflows and patient outreach. I am motivated to transition into pharmaceuticals where I can apply site experience, attention to detail, and effective communication in fast-paced, regulated environments.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Research Coordinator

Current

The Johns Hopkins University

Sep 2024 - Present (1 year 4 months)

Coordinates and oversees ALS clinical trial operations including study start-up, recruitment, informed consent, and regulatory management; led site execution for a randomized double-blind Phase II trial and ALL ALS study while ensuring GCP/ICH compliance and data integrity.

Clinical Trial Management REDCap Patient Recruitment EDC

Clinical Research Coordinator

The Johns Hopkins University

May 2024 - Sep 2024 (4 months)

Coordinated clinical research activities, ensured protocol compliance and data integrity, managed participant scheduling and documentation, and supported ALS clinic assessments including breathing tests and questionnaires.

Compliance Data Entry EDC Spirometry Clinical Assessment Query Resolution

Healthcare Management Intern

Caedel Medical Group, PC

Aug 2023 - May 2024 (9 months)

Managed back-office operations and medical record audits for a multi-office practice, led marketing initiatives to increase visibility, and ensured accurate, timely data entry to support practice operations.

Regulatory Compliance Data Entry Practice Operations Strategic Marketing HIPAA

Referrals Manager

East Harlem Health Outreach Partnership

Sep 2021 - Jan 2023 (1 year 4 months)

Managed patient referrals and education, tracked and documented referral workflows, and coordinated communication with healthcare providers and community agencies to ensure accurate access to services.

Referral Management Patient Education Documentation Data Tracking Confidentiality

Education

Degrees, certifications, and relevant coursework

Icahn School of Medicine at Mount Sinai

Master of Science, Biomedical Sciences

2022 - 2023

Activities and societies: Master thesis research; publication in The Journal of Developmental Biology

Completed a Master of Science in Biomedical Sciences with a thesis investigating cleft palate in Apert syndrome using an epithelium-specific Fgfr2+/S252W mouse model.