Part of the team responsible for building a cohesive Center of Excellence to support theglobal organization. Responsible for driving product innovation and maintenance ofregulatory compliance for clinical study operations from concept through launch to endof product life. Implementing an agile clinical trial service model, supported by strategicpartners, harmonized processes and turnkey tools to complement and optimize clinicalevidence generation across the organization.

Oversight of the evidence generation programs for the Surgical Business Unit. This involves the strategic planning and execution of global clinical studies for knee, hip, shoulder, and finger orthopedic implants. I was also responsible for oversight of the operational and financial portions of the Clinical Affairs team.

Responsible for the development of post-market research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.

In this role I collaborate with cross-functional team members to design and develop PMCF plans and associated clinical studies which will generate evidence for the company's products.

Responsible for the day-to-day management of investigational, pre- and post-market clinical studies: -Create and maintain study timelines, -Maintain accurate study status in CTMS, -Facilitate IRB/Ethics committee submissions, -Liaise with product teams and in-country sales and marketing personnel, to ensure effective study --alignment with product strategy throughout the design, implementation and lifetime of the study. -Work closely with data management group from study design through to reporting of results; Assist in preparation of clinical study reports (CSRs), and regulatory documents and submissions. -Act as principal liaison between Smith & Nephew and investigators, Contract Research Organizations (CROs), central laboratories, and other study vendors; -Train investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on all study procedures. -Monitor studies, or provide oversight of monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew procedures. -Participate in internal/external study-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary.-Contribute to scientific publications in international peer-reviewed journals and other publications, conferences, and other media, as appropriate.

Participate on product development teams to ensure US and other international clinical regulatory requirements are incorporated as part of the development process. Develop clinical trial pathways, protocols, and associated documentation to support regulatory submissions. Identify and create partnerships with external sites, collaborators, and/or consultants. Assist with development of clinical education programs and training of in-house and external stakeholders. Support/advise labeling, marketing, product transfer and literature review from a clinical perspective. Collaborate with and advise other executive team members regarding current and future product development plans from a clinical perspective.

Clinical and non-clinical trial development and support.Monitor clinical trial sites as part of our Clinical program.Perform basic data and statistical analysis as needed.Develop educational programs for internal and external partners.Participate on product development teams to support and further clinical claims.Draft reports which support marketing claims.Maintain Clinical Affairs SOPs, literature, other documentation.

After interning with this company for about a month and a half on several ophthalmology-related projects, the president of the company asked me to join them to write articles on various topics within the regulatory affairs field & dealings with the FDA. I have since written 2 published articles in the span of 1 month.

Handled all of the regulatory and patient records for the sponsored and PI-initiated studies. Handled study drug, patient contact, study coordination, grant preparation, budget negotiation, etc.

Coordinate all clinical research for the Cornea Clinic under the direction of Drs. Sugar, Soong, Mian and Shtein.

Molecular biology benchwork, animal husbandry, tissue culture, high-throughput screening, microbiology, cloning, ELISAs, etc.

Worked in the field of DNA repair studying the MRN complex.

Molecular biology benchwork, animal husbandry, cloning, tissue culture, PCR, etc.

QA/QC of formulations, analysis of used specimens, R&D on new formulations.