Clinical Research Manager

Susana Perez Martinez

502-***-**** Cape Coral, FL 33909 ad5ryq@r.postjobfree.com linkedin.com/in/susanaperezmartin3z

WORK EXPERIENCE

Clinical Research Manager at Argus Research Center, Inc./Tyson Eye, Cape Coral, FL 2022-Present

Adhere to FDA and GCP guidelines when implementing research trials to ensure the highest quality of research.

Implement timelines and workflow to ensure successful execution of clinical trials.

Elaborate and implement standard operating procedures that align with studies protocols.

Review research specifications and assign resources accordingly.

Analyze and interpret research data to ensure the data meets necessary regulatory standards.

Clinical data entering utilizing multiple electronic data capture and management systems including Medidata Rave, Castor, and Veeva Vault.

Review and negotiate contracts (enrolled 7 new studies) and budgeting ($890,758 revenue) with clinical research sponsors (Zeiss, Aerie, Alcon, AbbVie Pharmaceuticals, Iantrek, Oculight, Acufocus, Bausch+Lomb).

Oversee research coordinators and staff activities including training, performance, evaluation, and mentorship.

Screen patients record for identification of prospective candidates for research protocols.

Monitor clinical operations and logistical aspects of assigned Phase I-IV trial from start-up to close-out.

Cultivate cross-functional relationships with clinical research sponsors, CROs, physicians, and IRB.

Schedule and organize meetings with Principal Investigator, Sub-Investigators, sponsors, medical director, and CROs.

Prepare applications, renewals/continuation, protocol deviations, and close-out reports for the IRB (Alpha, Advarra, WCG).

Elaborate source documents for data collection, monitor study files, and review regulatory documents and informed consent.

Maintain complete and accurate study documentation for monitor and auditor visits readiness.

Manage and maintain coordinators’ payroll.

Doctoral Research Scientist at University of Louisville, Louisville, KY 2017-2022

Pre-Clinical Research Study Innovation and Development

Knowledgeable innovator skilled in cellular, molecular, developmental biology and genetics, as evidenced by the creation, design, planning, development, and collaboration of various multifaceted research projects:

- Leading studies on prenylation (which plays a role in 20-40% of human cancers and in other health problems) and its components: function and regulation of genes and proteins.

- Collaborated with engineers on COVID-19 research studies about sterilization of surfaces and creation of manufactured surfaces like nanodiamonds that prevent the deposit of bacteria, fungi, and viruses.

- Characterization and application of novel plant biomass enhancements to replace fossil fuels in the bioeconomy to produce biofuels and biodegradable plastics.

- Investigating the functional roles of uncharacterized genes that were found to have an essential function in growth and development and the sensing and response to the nutrient and energy status in Physcomitrium patens.

- Studying the establishment of multicellularity in plants and the function of proteins in Arabidopsis gamete development.

Scientific Writing-Communication-Data Analysis

Scientific and regulatory knowledge with the ability to plan, write, and review protocols, manuscripts, scientific articles, grant proposals, and educational documents. Evidenced by:

- Elaborating and teaching 4 courses in science including Genetics, Developmental Biology, Molecular Biology, and Biochemistry.

- Writing and revising 5 scientific articles and 6 successful NSF-OIA and NSF-IOS grant proposals bringing $1M of funding to our laboratory.

Self-motivated and independent decision-maker with experience in effectively interpreting, presenting, and communicating scientific results and data.

- Resulting in 10 oral presentations in scientific conferences and universities, with more than 5 oral presentations in schools.

Project and People Management

Project leader of multi-team projects including design, execution, forming teams, monitoring progression, measuring performance, and data collection and analysis as evidenced by leading 5 high-caliber research projects.

Strong reporting and documentation skills managing inventory of equipment and supplies related to study needs. Developing and maintaining budgets and resources ($1M in grant funding), ordering materials, and liaising with vendors, providers, and staff.

Mentorship expertise as evidenced by training, monitoring, and supervising professionals, and more than 50 students from diverse backgrounds on protocols, methodology, troubleshooting, and 15+ cell biology and high throughput biochemical techniques.

Cross-functional Collaboration

Demonstrated effective leadership and strong interpersonal skills by building and fostering cross-functional collaborations with research scientists, engineers, and other professionals from diverse backgrounds on various scientific projects, trainings, and educational materials.

Served in the Faculty Search Committee where I collaborated with other members to review, evaluate, and select outstanding and diverse faculty to become part of the department community.

EDUCATION

University of Louisville, Louisville, KY

Doctor of Philosophy (Ph.D.)- Molecular/Cellular/Developmental Biology and Genetics 2019-2022

Master of Science (M.Sc.)- Cell Biology 2017-2019

Bachelor of Arts (B.A.)- Molecular Biology 2013-2017

PROFESSIONAL SKILLS

Protocol Design & Supervision Research Study Development Clinical Trials Operations from Strat-ups to Close-outs Ophthalmic Clinical Research Contract and Budgets Negotiation Project & People Management ICH-GCP Guidelines Knowledge Clinical & Scientific Terminology Communication & Leadership Skills Data Collection, Analysis & Entering Electronic Data Capture and Management Systems Relationship Building & Teamwork Creative Problem-Solving Proactive & Adaptable Microsoft Office & Google Suite Snapgene & ApE NIS-Elements Viewer & ImageJ EndNote-PubMed

TECHNICAL SKILLS

Technical-Scientific Writing and Presentation

Patient Screening and Randomization.

Consenting Clinical trial Subjects.

Data entry and management using EDC systems.

Elaboration and implementation of Source Documents for Data Collection.

Gene knockout and knockdown.

Transformation of bacteria, yeast, and plant cells.

miRNA silencing using artificial microRNAs.

Molecular cloning, transformation, RT-PCR, allele-specific PCR, qPCR, colony PCR, gel electrophoresis.

DNA/RNA/Protein/Lipids/ Hormones/ Terpenoids: quantification, extraction, purification, sequencing, synthesis, Bradford assay, SDS-PAGE.

Light, Fluorescent, Confocal, and Dissecting Microscopy.

Bacterial, yeast and plant cell culture and high through-put selection and screening of transgenic cells on solid media and soil.

Biochemical assays: HPLC, GC/MS, FTIR, XRD, Hydrolysis, Solid assay, Fermentation.

CERTIFICATIONS

CITI Good Clinical Practice ASCLS P.A.C.E Transporting Dangerous Goods

CITI Investigator- Basic/Refresher Ophthalmic Medical Assisting (OMA)

CITI Human Subject Research

LANGUAGE COMPETENCIES

Spanish: native proficiency

English: full professional proficiency

PUBLICATIONS-MANUSCRIPTS-CLINICAL TRIALS

Bao, L., Ren, J., Nguyen, M., Slawomir Slusarczyk, A., Thole, J.M., Perez Martinez, S., Huang, J., Fujita, T., and Running, M.P (2022). The cellular function of ROP GTPase prenylation is important for multicellularity in the moss Physcomitrium patens. DOI: 10.1242/DEV.200279

White, A.J., Perez Martinez, S., and Running, M.P. (2021). The Effects of PPAL-1 in Arabidopsis Gamete Development. The Cardinal Edge 1(1),11. DOI: 10.18297/tce/vol1/iss1/11

Perez Martinez, S., Hossain, Md. A., and Running, M.P. Characterization of novel moss biomass, Physcomitrium patens, as a candidate biomass feedstock for biofuel production.

Perez Martinez, S., Bao, L., and Running, M.P. The biological and developmental roles of PPAL in the moss Physcomitrium patens.

Perez Martinez, S., Jung, Hyun., and Running, M.P. PpPPAL is needed to sense and respond to the available nutrient and energy status and to mediate glucose and hormone signaling in Physcomitrium paten.

2023 Oculight Co., Ltd., OCL-IIC-01 V1.0, “Prospective Randomized, Paired-Eye, Comparative Study Between Cataract Surgeries with and without an Illuminated Chopper.”

2023 AcuFocus, Inc., SAIL-101-PAS2, “IC-8 Apthera IOL New Enrollment Post Approval Study.”

2023 ZEISS, MICOR-304-103, “A retrospective multicenter chart review of patients who have undergone cataract surgery with the MICOR surgical instrumentation device”

2023 Character Biosciences, Inc., 2021001, “A decentralized epidemiological study of the progression of primary open-angle glaucoma and glaucoma subtypes.”

2023 AbbVie Pharmaceuticals, Inc., M22-068, “Evaluation of the safety and efficacy of dexamethasone intravitreal implant for the treatment of persistent pseudophakic cystoid macular edema (PCME).”

2022 Aerie Pharmaceuticals, Inc., AR-15512-C5302, "A Phase: 3Study Evaluating the Safety and Efficcy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3]."

2022 lantrek Inc., IT-CYC-041, "A registry study of safety and effectiveness outcomes through 24 months postoperatively following CycloPen Cyclodialysis System Proceduresi n Patients with Open Angle Glaucoma."

2022 ZEISS, MICOR-304-102,"A Prospective, multicenter study to assess the clinical outcomes of low energy lens fragmentation cataract extraction in patients undergoing cataract surgery."

2021 TearClear Corp., TC-002-201, "An Open-label, Multi-center, Active Controlled, Prospective Pilot Study Assessing the Safety, Tolerability and OcularHypotensive Efficacyof TC-002 Ophthalmic Solution (TearClear Latanoprost Ophthalmic Solution 0.005.%) Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects with Elevated Intraocular Pressure.”

2021 ADX-102-DED-023 The TRANQUILITY 2 Trial: A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.

2021 Alcon GLD122-P004 An Observational Multicenter Clinical Study to Provide Additional Long-Term Follow-Up Beyond 60 Months for Subjects Implanted with a CyPassMicro-Stent in the COMPASS Trial.

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