Alexandra Fuller Email & Phone Number

Leicester, Nc, Us

Dublin , Gb

Monroeville, Pa, Us

• Develops plans for the analysis of aggregate clinical data to assess trends in device safety and device performance.• Maintains a strong knowledgebase in medical devices regulations.• Supports EU marketing submissions for medical devices by acting as a scientific strategic resource for the presentation and interpretation of clinical data, in collaboration with client subject matter experts, and authoring Clinical Evaluation Reports (CERs) in compliance with EU MDR and following MEDDEV 2.7/1, Rev. 4.

Chapel Hill, Nc, Us

• Led or participated in crossfunctional client meetings.• Provided project management support including developing project timelines and tracking of outstanding items.• Supported various clients with regulatory medical writing including clinical research protocols (phase I/II), clinical study reports (CSRs; phase II or III), initial Investigator Brochures (IBs), and modules for 505(b)(2) submissions (Module 2.4 and Module 2.6.2) for global clinical studies/programs. Supported medical device clients with EU MDD CERs and associated documents.• Reviewed tables, listings, and figures (TLFs) for CSRs

Nashville, Tennessee, Us

• Supported both regional and global clinical studies (phase I/II and phase II) on triple-negative breast cancer, hormone receptor positive breast cancer, multiple myeloma, acute myeloid leukemia, chronic lymphocytic leukemia, pilocytic astrocytoma, non-small cell lung cancer, and bone marrow transplant (BMT) and graft-versus-host disease (GVHD).• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites, vendors)• Liaised between study sites and the Sponsor for safety reporting, corrective action plan (CAPA) resolution, data management, biospecimen processing, and IRB communications. Also issued queries to sites.• Generated reports from the EDC to assess study protocol compliance, patient enrollment, and safety trends. Presented reports to Sponsor-investigators as well as pharmaceutical funders.• Reviewed incoming SAE reports (MedWatch) and submitted these forms to the FDA per the reporting requirements. Also performed AE/SAE reconciliation and communicated findings to Sponsor-investigators and pharmaceutical funders. • Drafted Expanded Access protocols (single patient), protocol amendments (single and multisite), and IND annual reports.• Reviewed and updated existing ICFs as well as authored new ICFs.• Assisted with study closeout activities for regional studies.

Monroeville, Pa, Us

• Acted as the primary author of Clinical Evaluation Reports (CERs) in compliance with EU MDD or EU MDR and following the MEDDEV 2.7/1 rev 4 guidance.• Analyzed and summarized medical device risk documentation, periodic safety update reports, and patient instruction for use documents.• Collaborated with research librarians to perform systematic searches of clinical literature and clinical trials, and summarized and weighted relevant results for inclusion in the CERs.• Worked with the internal team and pharmaceutical collaborators to obtain an in-depth understanding of products and produce high-quality deliverables.

Nashville, Tennessee, Us

• Recipient of the Vanderbilt Vision Research Center (VVRC) Training Grant.• Played a key role in the design of preclinical experiments using cutting-edge technology including CRISPR/Cas9 and single-cell RNA sequencing.• Developed and characterized zebrafish and mouse disease models for cardiac stress, cataract formation, and impaired retinal development.• Drafted protocol amendments for animal studies, comprehensive review articles, publications, and posters.• Gathered, reviewed and summarized both preclinical and clinical research literature from scientific journals, as well as unpublished experimental findings.• Checked incoming data for accuracy and integrity to identify and resolve problems.• Maintained laboratory operations, following Institutional Animal Care and Use Committee (IACUC) policies and Good Laboratory Practices (GLP).• Completed a 3-year certificate program on the principles of clinical research, with an emphasis on human subject protections and clinical literature interpretation (peer-reviewed journals).• Fostered new interdisciplinary scientific collaborations.• Observed patient diagnosis by shadowing an ophthalmologist and cardiologist as well as attending Grand Rounds.

Rockville, Maryland, Us

• Performed high-throughput screening and characterized structure-activity relationships (SAR) for novel antimalarial drug candidates.• Successfully executed key research projects which resulted in 2 research publications and a patent.• Presented experimental findings at meetings with pharmaceutical collaborators (Microbiotix) and at the departmental seminar.

Atlanta, Ga, Us

• Contributed to scientific discoveries in many disciplines including art restoration science, polymer materials, and plant biology• Communicated scientific findings in peer-reviewed publications, as well as posters and oral presentations

Master Of Science - Ms, Cell And Developmental Biology

Bachelor Of Science (Bs), Chemistry