Diana Abdelgani
Houston,Tx
Summary
Results-driven clinical research manager with extensive hands-on experience and a passion for cultivating talent and fostering compliant, high-performing teams. Seeking a Clinical Research Director role to apply expertise in overseeing all operational aspects of clinical trials, managing multiple concurrent studies, and developing best practices that drive organizational growth and success.
Overview
12
12
years of professional experience
4
4
Certifications
Work History
Senior Clinical Research Coordinator (Clinical Research Site Manager)
Retina & Vitreous of Texas, PLLC
06.2013 - 08.2025
- Directed all operational functions across the research sites to ensure efficient, compliant, and high-quality conduct of clinical trials in Phase 1-4. (Investigational drug, Medical Devices, Gene therapy, Surgical)
- Managed all aspects of study execution from initiation through close-out, ensuring adherence to timelines, protocols, and internal processes.
- Developed and implemented all standard operating procedures for all aspects of the research department
- Developed and executed detailed operational plans for each study, including resource allocation, staffing, and equipment needs.
- Oversaw data integrity through routine documentation review, source verification, and timely, accurate data entry and reporting.
- Managed CTMS (Realtime and CRIO)
- Managed multiple vendors for the site
- Reviewed and approved CDA, vendor and clinical trial agreements including budgets
- Conducted all site feasibility visits and assigned clinical trials
- Ensured full regulatory compliance with GCP and ICH guidelines, always maintaining comprehensive documentation and audit readiness.
- Proactively identified and addressed performance trends, implementing corrective and preventive actions to improve operational efficiency and quality standards.
- Oversaw the submission of timely and accurate regulatory reports, meeting all sponsor and regulatory deadlines.
- Managed and audited the site’s master training files, ensuring all staff certifications, licensure, and training records were current and compliant.
- Recruited, trained, and managed a high-performing team of site staff, providing comprehensive onboarding and ongoing supervision.
- Fostered a patient-centric research environment and led regular site team meetings to address operational challenges and ensure consistent communication.
- Implemented patient recruitment strategies to consistently meet or exceed enrollment goals for all clinical trials.
- Monitored and managed site-level revenue and expenses, collaborating with leadership and finance to achieve financial targets and maximize profitability.
- Served as the primary point of contact for sponsors, CROs, and vendors for the site ensuring transparent communication, resolving issues, and aligning on study deliverables.
- Cultivated professional relationships with affiliated physicians, monitors, and sponsor representatives to facilitate streamlined operations and collaboration.
- Coordinated site investigations, documented issues, and escalated to executive teams.
- Interviewed, hired, and trained new workers on site processes.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Provided onsite training to help develop employee skills in both clinical research and ophthalmology .
Education
Bachelor of Science - Healthcare Administrations
University of Houston-Clear Lake
05-2026
Associates of Applied Science - Eye Care Technology
San Jacinto College
05.2013
Skills
- GCP compliance management
- Strong Knowledge of ALCOA guidelines
- Budget management
- Source evaluation
- Proficient in Word
- Proficient in Excel
- Proficient in Spanish
- Efficient multitasking
- Site management procedures
- Quality control management
- Process optimization
- Vendor Management
- Attention to detail
- Detail-oriented organization
- Effective communication
- Analytical problem solving
- Judgment skills
- Collaborative team development
- Effective team leadership
- Effective relationship management
- Effective listening skills
- Supportive care for patients
- Clinical Research oversight
- Subject recruitment
- Strategic program leadership
- Employee training
- Operational efficiency management
- Process optimization
- Inventory management
- Trends analysis
- SOP development
- Business development
- Site inspection and management
- Contract negotiation
- Budget negotiation
Accomplishments
- Increased the number of clinical trial studies by 300% within 3 years of joining the practice, expanding the site's research portfolio.
- Aug 2018- Received Site recognition by Genentech for most enrolled site across a global study.
- Feb 2019-Aug 2019 - Received site recognition by Genentech for First subject screened and most enrolling site.
- Sep 2020, I began managing budget negotiations and increase cost per patient by 66% across all clinical trials increasing financial revenue. Worked closely with executive leaders to developed an incentive program for clinical research coordinators to motivate increase trial enrollment and was used across all affiliated sites.
- Created study coordinator training material and new hire onboarding site training plan that was used across all affiliated sites.
Certification
- ACRP-Certified Clinical Research Coordinator(CCRC) May 2020-Active
- JCAHPO-Certified Ophthalmic Technician (COT) May 2014-Active
- Good Clinical Practice Certification (GCP) June 2023-Active
- IATA Certification Nov 2024- Active
Clinical Research Experience
- Diabetic Retinopathy Clinical Research Network Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity 2013-2013.
- Diabetic Retinopathy Clinical Research Network Short-term Evaluation of Combination Corticosteroid+Anti-VEGF Treatment for Persistent Central-Involved Diabetic Macular Edema Following Anti-VEGF Therapy in Pseudophakic Eyes 2013-2018.
- Diabetic Retinopathy Clinical Research Network A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema 2014-2018.
- Diabetic Retinopathy Clinical Research Network Prompt Panretinal Photocoagulation versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy 2014-2016
- Score2 NIH (National eye institute) Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2): a multicenter, prospective, randomized non-inferiority trial of eyes with macular edema secondary to central retinal vein occlusion, comparing intravitreal bevacizumab every 4 weeks with intravitreal aflibercept every 4 weeks. 2014-2016.
- Hawk Study RTH258-001 Alcon Research Ltd. Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration 2015-2018.
- Aerpio- AKB-9778 CI 5001- Trial runners Phase 2 Double-masked, Placebo-controlled Study To Assess The Safety And Efficacy of Subcutaneously Administered AKB 9778 15mg Once Daily Or 15mg Twice Daily For 12 Months in Patients with Moderate To Severe Non-Proliferative Diabetic Retinopathy - 2017-2019.
- Yosemite GR40349 –Genentech- Roche Ltd A Phase 3, Multicenter, Randomized, Double-masked, Active Comparator Controlled Study to Evaluate the Efficacy and Safety Ofro6864761 in Patients with Diabetic Macular Edema- 2018-2021.
- Tenaya GR40306 –Genentech-Roche ltd A Phase 3, Multicenter, Randomized, Double-Masked, Active Comparator Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age Related Macular Degeneration. 2019-2022
- Raven CRTH258C2302- Novartis Pharmaceuticals An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase 3 Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Edema secondary to Central Retinal Vein Occlusion. 2019-2021
- Pagoda GR40550: Genentech- Roche Ltd- Surgical Device Trial A Phase 3, Multicenter, Randomized, Visual Assessor Masked, Active Comparator Study of The Efficacy, Safety, And Pharmacokinetics of The Port Delivery System with Ranibizumab in Patients with Diabetic Macular Edema. 2019 To 2025
- Pavilion GR41675: Genentech- Roche Ltd- Surgical Device Trial A Phase 3 Multicenter, Randomized Study of The Efficacy, Safety, And Pharmacokinetics of The Port Delivery System with Ranibizumab in Patients with Diabetic Retinopathy. 2020 To Present
- Rhone-X GR41987: Genentech- Roche Ltd A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema. 2020 To 2023
- Gather2 ISEE2008: Iveric Bio A Phase 3 Multicenter, Randomized, Double-Masked, Sham controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) In Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration. 2021 to 2023
- Condor CRTH258C2301: Novartis Pharmaceuticals Novartis Pharmaceuticals trial entitled: A 96-week, two- arm, randomized, single-masked, multi-center, phase 3 study assessing the efficacy and safety of brolucizumab 6mg compared to panretinal photocoagulation laser in patients with proliferative Diabetic Retinopathy. 2021 to 2023
- Balaton –GR41984 Genentech Roche Ltd A Phase 3, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Branch Retinal Vein Occlusion- 2021 – 2023
- Comino- GR41986 - Genentech Roche Ltd A Phase 3, Multicenter, Randomized, Double-Masked, Active Comparator -Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion- 2021 -2023
- GR43828 - Genentech Roche Ltd A Phase I, Multicenter, Open-Label Study of The Safety, Tolerability, Pharmacokinetics, And Immunogenicity of Intravitreal Injections of RO7446603. 2022 to 2025
- Dream OTT166-201 Ocuterra Pharmacutical, A Phase 2 OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR) Jan 2023- Apr 2024
- Parasol 81201887MDG2001 -Janssen Phase 2B -Dry AMD- GA (Gene Therapy) A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ 81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) May 2023-Aug 2025
- Elevatum, ML43435 Genentech Phase 3B DME Multicenter, Open-Label, Single-Arm Study To Investigate Faricimab (Ro6867461) Treatment Response In Treatment-Naïve, Underrepresented Patients With Diabetic Macular Edema Feb 2022- Aug 2025
- EYE 103-101 Eyebio Tech 1b/2a, An open label multiple ascending dose (MAD) safety study, and a dose-finding single masked comparative safety and preliminary efficacy study of intravitreal (IVT) EYE103 in a mixed population of participants with diabetic macular edema (DME) and neurovascular age-related macular degeneration (NVAMD). Sep 2023-Dec 2024
- Atmosphere RGX-314-2104 RegenxBio Phase 2b/3, Wet AMD (Gene Therapy) A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD . Oct 2023- Aug 2025
- Insite 2022-01 Mcmaster University Phase 4, McMaster University DME Treat & Extend versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial. Mar 2024- Aug 2025
- Burgundy BP41670 -F Hoffman La Roche Ltd Phase 1, Wet AMD A THREE-Part, Phase I Study to Investigate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Zifibancimig Following Intravitreal Administration Of Multiple Ascending Doses And Continuous Delivery From The Port Delivery In Patients With Neovascular Age-Related Macular Degeneration. Dec 2023- Aug 2025
- GION KDK-1101-022 Kyoto Drug Discovery & Development Co., Ltd. A Phase 2, Double-masked, Randomized, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO). Jun 2024- Mar 2025
- Brunello EYE-RES-102 - Eyebio Tech 2/3, A Randomized, Double-Masked, Multicenter, 3-Arm Pivotal Phase 2/3 Study To Evaluate The Efficacy And Safety Of Intravitreal Eye103 Comparedwith Intravitreal Ranibizumab (0.5mg) In Participants With Diabetic Macular Edema. Oct 2024- Aug 2025
- Lugano EYP-1901-301 EyePoint Pharmaceuticals, Inc A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD. Nov 2024- Aug 2025
Languages
Spanish
Professional Working
Interests
- DIY and Home Improvement
- Volunteering for community initiatives to give back to local communities and make a positive impact
- Soap Making
Presentations
- Macular Degeneration- Co-Presenter
Oral Presentation with slide deck
RVT Lunch and Learn | January 16th 2025
Detailing the differences between wet and dry AMD, clinical findings, and risk factors such as genetics, aging, and smoking. The presentation also outlined diagnostic procedures and current and emerging treatment therapies.
- Pre-Screening tips for Geographic Atrophy in AMD -Co-Presenter
Oral Presentation with slide deck
RVT Lunch and Learn | August 15th 2024
Detailing common reasons for patient screen failures in geographic atrophy clinical trials and providing strategies to mitigate them.
- Clinical Trial Compliance and FDA Audit
Oral Presentation with slide deck
RVT Lunch and Learn | March 11th 2023
Detailing regulatory compliance in clinical research GCP, ICH guidelines and providing FDA audit preparation tips
Timeline
Senior Clinical Research Coordinator (Clinical Research Site Manager)
Retina & Vitreous of Texas, PLLC
06.2013 - 08.2025
Bachelor of Science - Healthcare Administrations
University of Houston-Clear Lake
Associates of Applied Science - Eye Care Technology
San Jacinto College
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