Dr. Judy Jean

Keiser University

Academic Program Coord. Faculty / Professor – Doctor of Health Science Program
March 2022 – Present

• Provide academic and operational leadership for the Doctor of Health Science (DHSc) program, ensuring curriculum quality, student success, and accreditation alignment.
• Serve as Dissertation Chair and Committee Member, mentoring doctoral learners through IRB submission, proposal development, data analysis, and final defense.
• Analyze assessment and program outcome data to guide curriculum enhancements and continuous improvement initiatives.
• Lead student retention and progression efforts through structured advisement, mentoring, and academic support.
• Instruct graduate-level courses in Health Science, Research Methods, and Health Services Administration.
• Collaborate with institutional leadership to maintain compliance with academic and regulatory standards.

Penn State Cancer Institute – Clinical Trials Office (Remote, Contract via Advarra)

Educator -Research Operations
April 2023 – October 2023

• Developed and implemented clinical research education and onboarding curricula for oncology research staff.
• Conducted gap analyses to assess training, compliance, and operational needs across research teams.
• Supported regulatory readiness and standardization of research education in alignment with institutional and federal requirements.

Duke Clinical Research Institute (Remote, Contract)

Project Leader – Community-Engaged Research
March 2022 – August 2022

• Led government-funded, community-engaged research initiatives with a focus on ethical participation and stakeholder collaboration.
• Coordinated advisory boards and research committees to ensure regulatory compliance and community trust.
• Facilitated cross-functional communication between sponsors, leadership, and community partners to support project outcomes.

Premier, Inc. (Remote)

Director of Research Operations
September 2019 – January 2022

• Directed multi-site clinical research studies from start-up through closeout, ensuring adherence to timelines, budgets, quality standards, and regulatory requirements.
• Led cross-functional teams consisting of investigators, research coordinators, data managers, sponsors, and external stakeholders.
• Managed study start-up activities including site selection, feasibility assessments, IRB submissions, study documentation, and operational planning.
• Oversaw study enrollment performance, developed recruitment strategies, and implemented risk mitigation plans to achieve project milestones.
• Managed vendor relationships, study budgets, contracts, and project deliverables.
• Ensured inspection readiness through maintenance of essential study documentation and compliance with ICH-GCP and applicable regulations.
• Led issue resolution, escalation activities, and CAPA planning.
• Supported database lock activities, data review processes, and quality management initiatives.

St. Mary’s Medical Center / Palm Beach Children’s Hospital

Clinical Research Manager
August 2018 – September 2019

• Managed pediatric and oncology clinical trials from initiation through study completion.
• Coordinated study start-up activities including site activation, regulatory submissions, investigator documentation, and site readiness.
• Supervised Clinical Research Coordinators and collaborated with investigators, sponsors, and institutional leadership.
• Monitored enrollment performance and implemented strategies to support recruitment goals.
• Conducted compliance reviews, internal audits, and quality oversight activities.
• Maintained study documentation and supported inspection and audit readiness efforts.
• Facilitated resolution of operational issues and protocol deviations while ensuring timely escalation.

Miami Children’s Hospital

Manager, Clinical Research Projects | Clinical Research Coordinator I
January 2005 – March 2011

• Coordinated clinical trial operations across multiple therapeutic areas including study start-up, regulatory submissions, patient enrollment, and study closeout activities.
• Served as primary liaison between investigators, sponsors, research staff, and regulatory bodies.
• Maintained study documentation, regulatory files, and research databases in accordance with GCP requirements.
• Supported monitoring visits, audit preparation, and resolution of study-related findings.
• Assisted with patient recruitment initiatives and enrollment tracking.
• Successfully achieved top enrollment performance for a multi-year endocrinology clinical trial.

Spectrum Programs, Inc.

Senior Research Associate
September 2001 – May 2005

• Supervised data quality, staff performance, and protocol adherence for research and evaluation projects.
• Supported grant writing, accreditation reviews, and evidence-based program evaluations.
• Promoted twice during tenure while completing graduate education.

“My goal is to support students and research teams through education, mentorship, and evidence-based practice while promoting quality, ethical research, and meaningful contributions to health science.”