Leslie Marcus, CCRC

Experience

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  Csra Partners In Health

  May 2000 - Jun 2001

  Research Assistant | Nutritionist | Clinical Trials | Subject Recruitment

  Early in my career, I gained essential experience as I reviewed clinical trials for this medical practice.SECURED 100% OF CLINICAL TRIAL SUBJECTS IN ONE DAY TO ACHIEVE TOP RECRUITER RECOGNITION FOR SITE.➙ Ensured comprehension and voluntariness of trials; scheduled Screening & Enrollment visits; stored & administered research drugs; and updated, corrected & reviewed data in clinical databases.

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  Georgia Retina, PC

  Oct 2001 - Jul 2004

  Clinical Research Coordinator & Ophthalmic Technician | Ophthalmology Research | Program Development

  I gained vast experience in my initial roles at Georgia Retina, and advanced to Clinical Research Coordinator to startup essential programming. This role built on prior experience in my initial role Ophthalmic Technician, and later as Lead Technician and Surgical Assistant. I guided clinic flow management and also coordinated staff work assignments, patient education, and treatment administration.PLAYED INTEGRAL ROLE LAUNCHING CLINICAL RESEARCH PROGRAM ACROSS OPHTHALMOLOGY PRACTICE➙ Assisted in implementing clinical research program across ophthalmology practice. Collaborated with pharmaceutical companies; recruited & enrolled study patients; trained staff; assessed & reported adverse events.➙ Drove site’s recognition as top enroller in southeast after achieving recruitment goals for pivotal Age-Related Macular Degeneration study.➙ Supported surgeries: handled surgery scheduling, assisted surgeon, and maintained sterile field using aseptic technique. Show less

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  Drug Studies America

  Jul 2004 - Feb 2007

  Clinical Research Coordinator | Quality Assurance | Clinical Study Management | Data Management

  During this time, I collaborated with pharmaceutical companies involved in research, and led chart review as Quality Assurance (QA) Specialist. This encompassed completing and correcting case reports following CRA reviews. I also collected & shipped laboratory specimens and stored & administered research drugs.SOLIDIFIED ORGANIZATION’S CAPACITY TO DELIVER ACCURATE, RELEVANT DATA➙ Established reputation of providing quality data in compliance with regulatory and GCP standards by enhancing data and minimizing errors as Quality Assurance Specialist and while performing routine chart reviews.➙ Recruited, enrolled, and retained study patients in research protocol according to inclusion/exclusion criteria.➙ Liaised between patients and physician about complaints and illnesses; obtained vital signs; assessed & reported adverse events to IRB and sponsor. Show less

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  Georgia Retina, PC

  Feb 2007 - Mar 2023

  Director of Clinical Research | Leadership | Clinical Trials | Project Management

  I leveraged my expansive industry expertise to drive operations across clinical research studies and lead a team of 7 encompassing Clinical Research Coordinators, Research Assistants, and staff. I also lead policy & procedure development and compliance; patient & staff scheduling; and communications. I regularly liaised among physicians, staff, administration, and 14 clinic locations.ESTABLISHED DEPARTMENT THAT MAINTAINS 20+ CLINICAL TRIALS ANNUALLY➙ Expanded department to meet increased need for clinical trials. Outlined growth projections & challenges as well as projected profit margin.➙ Surged number of clinical trials. Initiated new studies after leveraging network to share information about facility and secured meetings with sponsors.➙ Ensured profitability from research by boosting individual clinical trial budgets. Reviewed contracts, ensured fees were invoiced, and negotiated budgets.➙ Grew team to 7 after expressing need for expanded team to support additional clinical trials; maintained exemplary data quality during growth.COMBINE BUSINESS & INDUSTRY EXPERTISE TO NURTURE POSITIVE, PRODUCTIVE CULTURE➙ Boosted productivity, increased safety, and created welcoming environment by spearheading move to larger office. Researched new space, secured funding, and designed expanded study suite layout.➙ Enabled team to see more research subjects while maintaining exemplary care. Empowered staff to collaborate in creating new system that cut visit time without sacrificing service.➙ Organized regular charity involvement to maintain staff engagement and incite collaboration during pandemic. Show less

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  Lexitas Pharma Services

  Mar 2023 - Feb 2024

  Associate Study Manager | Ophthalmology | Clinical Research | Compliance

  In this role, I oversaw clinical research studies. This included development of all documents (Regulatory Binders, Procedure Manuals, newsletters, etc.); budget management; and vendor relations. I led meetings for diverse groups, including internal teams, CRAs, Study Coordinators, and sponsors. Additionally, I oversaw site tracking, encompassing enrollment, query resolution, investigational product transit & storage, and site support.MANAGE CLINICAL RESEARCH STUDIES AND TRIALS FOR LEADING PRODUCT DEVELOPMENT ORGANIZATION➙ Led studies focused on the anterior segment of the eye.➙ Developed essential study documents for sponsor, including newsletters, email blasts, Study Coordinator Forum meeting slides, Study Reference Manuals, and Regulatory Binders. ➙ Launched updated compliance app across 16 clinical research sites and spearheaded forum to provide key installation instructions; led troubleshooting and issue escalation.➙ Regularly organized and led internal and sponsor meetings. Show less

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  EyeSouth Partners

  Apr 2024 - now

  Clinical Research Director