Senior Manager, Research Support August 2023 to Present Bascom Palmer Eye Institute | University of Miami | Department of Ophthalmology• Provided professional research regulatory support and guidance for the Department of Ophthalmology at the University of Miami. • Executed study start-up activities department-wide, including feasibility reviews, budget and contract negotiations, protocol and informed consent form development, local and external IRB submissions, and regulatory document completion.• Acted as a liaison among industry sponsors, principal investigators, study coordinators, departments, IRB, ancillary committees, IDS Research Pharmacy, and Office of Research Administration during study start-up and throughout the study.• Provided training for new hires in the Clinical Research Service unit and conducted ongoing refresher training for research unit members, faculty, and staff.• Developed onboarding training agenda template and conducted tailored one-on-one training for 20+ employees.• Managed a team of 15 to 17 study coordinators. • Developed and led monthly educational team sessions titled the Brown Bag Series to inform and update the unit on regulatory and institutional policies and procedures. • Created the CRS Unit SOP Committee to update existing and compose new SOPs.• Implemented the Quality Assurance Initiative to ensure all CRS studies are complaint with regulations, policies, and procedures. • Conducted recurring monthly one-on-one meetings with all study coordinators to discuss concerns, review documentation, and develop corrective and preventive action plans. • Provided guidance and support during Research Quality Assurance (RQA) reviews.• Knowledge of institutional, IRB, and FDA regulations, policies, and procedures.• 14 years of prior experience in coordinating all aspects of clinical studies within the unit.• 2 years of prior experience in research management within the unit.

Regulatory Manager June 2021 to August 2023 Bascom Palmer Eye Institute | University of Miami | Department of Ophthalmology• Provided professional research regulatory support and guidance for the Department of Ophthalmology at the University of Miami. • Executed study start-up activities department-wide, including feasibility reviews, budget and contract negotiations, protocol and informed consent form development, local and external IRB submissions, and regulatory document completion.• Acted as a liaison among industry sponsors, principal investigators, study coordinators, departments, IRB, ancillary committees, IDS Research Pharmacy, and Office of Research Administration during study start-up and throughout the study.• Provided training for new hires in the Clinical Research Service unit and conducted ongoing refresher training for research unit members, faculty, and staff.• Developed onboarding training agenda template and conducted tailored one-on-one training for 10+ employees.• Managed a team of 5 study coordinators.• Developed and led monthly educational team meetings branded as the Brown Bag Series to inform and update the unit on regulatory and institutional policies and procedures. • Created and implemented quality assurance assessments for compliance.• Conducted monthly one-on-one meetings with study coordinators to discuss concerns, review documentation, and develop corrective and preventive action plans. • Established departmental implementation of Complion, the eRegulatory platform required by UM for FDA-regulated studies starting June 1, 2021. • Provided guidance and support during Research Quality Assurance (RQA) reviews.• Co-authored the research unit’s SOPs.• Knowledge of institutional, IRB, and FDA regulations, policies, and procedures.• 14 years of prior experience in coordinating all aspects of clinical studies within the unit.

• Provided professional level support for clinical trials involving human subjects • Executed studies to obtain FDA approval of medications that prevent loss of vision for patients with age-related macular degeneration, the leading cause of blindness in people over age 50 in the U.S.• Acted as liaison between principal investigator and industry sponsors including Genentech, Roche, GlaxoSmithKline, Apellis, Pfizer, Alcon, Regeneron• Implemented research protocols, trained study staff, and monitored adherence • Achieved compliance with university and IRB regulatory requirements • Established rapport with patients for successful study recruitment and retention• Coordinated effectively with study staff members (e.g. physicians, nurses, pharmacists, visual acuity examiners, ophthalmic photographers)• Collecting, processing, and shipping of lab samples according to safety specifications• Knowledge of medical terminology and FDA regulations for drug studies

Clinical Research Coordinator May 2007 to December 2017 Bascom Palmer Eye Institute | University of Miami | Department of Ophthalmology• Provided professional level support for clinical trials involving human subjects. • Executed studies to obtain FDA approval of medications that prevent loss of vision for patients with age-related macular degeneration, the leading cause of blindness in people over age 50 in the U.S.• Acted as a liaison between the principal investigator and industry sponsors including Genentech, Roche, GlaxoSmithKline, Apellis, Pfizer, Alcon, and Regeneron.• Implemented research protocols, trained study staff, and monitored adherence. • Achieved compliance with university and IRB regulatory requirements. • Established rapport with patients for successful study recruitment and retention.• Coordinated effectively with study staff members (e.g. physicians, nurses, pharmacists, visual acuity technicians, ophthalmic photographers).• Collecting, processing, and shipping of lab samples according to safety specifications.• Knowledge of medical terminology and FDA regulations for drug studies.

• Assessed marginal population at high risk for HIV infection • Coordinated with state and county departments of corrections in order to interview incarcerated clients • Maintaining contact and scheduling follow-up appointments with clients • Establishing rapport to elicit truthful responses concerning sensitive personal information • Organization and maintenance of confidential client files and data • HIV Counseling Certification - Pre-test and Post-test

• Tested a novel socio-behavioral therapy for Hispanic adolescents and their families • Completed thorough and accurate assessments of participants, including interviews, psychosocial questionnaires, and drug testing • Closely coordinated with therapists and organized team workload • Timely completion of sensitive assessments• Engaging adolescents for maximum honesty and participation in the program• Organization of confidential files and information • Responsible for petty cash flow • Establishing rapport, attention to detail, teamwork, and professionalism

• Participants of socio-behavioral intervention program consisted of men treated for localized prostate cancer• Contributed to the development of study protocol manuals • Completed sensitive psychosocial assessments of participants• Measured vitals and collected urine and saliva samples • Editing, translating, and graphic design skills • Data analysis