Danielle Williams
Clinical Research professional with over four years of experience leading Phase II-IV clinical trials from study startup through closeout in academic medical center settings. Experienced in clinical study execution, protocol implementation, regulatory strategy, CDISC-compliant data management, investigator collaboration, and cross-functional study operations. Proven ability to partner with sponsors, CROs, investigators, and multidisciplinary teams to deliver high-quality clinical research while ensuring compliance with FDA regulations, ICH-GCP guidelines, and institutional requirements. MBA-trained with a strong foundation in clinical research, operational leadership, and continuous process improvement.
Work History
Clinical Research Coordinator
- Directed operational execution of multiple Phase II-IV clinical trials from startup through closeout while maintaining study timelines and regulatory compliance.
- Served as the primary liaison among investigators, sponsors, CROs, pharmacists, laboratories, and institutional departments.
- Led study startup activities including IRB submissions, protocol implementation, site activation, and regulatory documentation.
- Coordinated monitoring, initiation, and closeout visit sites while ensuring inspection readiness.
- Reviewed clinical data and supported CDISC-compliant data collection.
- Managed investigational product accountability.
- Supported adverse event reporting and protocol deviation management.
- Collaborated with cross-functional teams to achieve enrollment and milestone goals.
- Contributed to scientific publications.
Biostatistics Research Coordinator
1 Year- Oversaw data quality and integrity for cross-departmental research projects.
- Reviewed CRFs and maintained databases using Excel, REDCap, and SAS.
- Collaborated with investigators and data teams to meet reporting deadlines and improve communication.
- Assisted with regulatory documentation to ensure compliance with institutional and federal standards.
Middle School Teacher
4 Years- Designed lesson plans and tracked performance for 20+ students.
- Communicated regularly with parents and administrators to support student growth.
- Developed strong organizational and communication skills applicable to team coordination and project planning.
Research Coordinator
1 Year- Supported environmental research projects focused on mercury contamination.
- Managed lab workflows and data reporting to meet university and regulatory standards.
- Helped plan project timelines and ensured adherence to safety protocols.
Education
Master of Business Administration (MBA) - Healthcare Administration
Bachelor of Science (B.S.) - Biology
Skills
Certification
- Good Clinical Practice (GCP), CITI Training – Aug 2022
- Foundations of Project Management, Coursera – Nov 2021
- PMP Candidate (TBD)
Timeline
Clinical Research Coordinator
Biostatistics Research Coordinator
Middle School Teacher
Research Coordinator
Cheyney University
Eastern University
Publications
Efficacy of Dupilumab on Facilitated Food Reintroduction in Eosinophilic Esophagitis: https://www.cghjournal.org/article/S1542-3565(25)00745-1/fulltext