Margarita Kleposki
Clinical Trials Specialist
Celina,TX
Summary
Detail-oriented Clinical Trial Specialist with 23 years of experience in supporting global studies across phases I-IV in pharmaceutical and CRO environments. Extensive background in managing imaging data, ensuring data accuracy, resolving discrepancies, and maintaining inspection-read documentation. Skilled in regulatory compliance, clinical operations support, and cross-functional collaboration. Seeking a role where I can contribute my expertise in documentation, process improvement, and quality-focused trial support in a dynamic, team-driven environment.
Overview
25
25
years of professional experience
Work History
Imaging Specialist, Medical Imaging & Cardiac Safety Solutions
ICON Clinical Research
11.2003 - Current
- Facilitate regular project reviews while overseeing patient data
management across multiple trials daily. - Manage data status while coordinating client-specific activities across all Lead studies.
- Execute consistent, on-time, quality delivery of study tasks (study start-up, maintenance, and close-out.
- Achieve rapid turnaround times daily on trials involving sensitive patient data.
- Execute image processing and quality assurance in alignment with over 13 clinical trial specifications at any given time.
- Managed submission and resolution of site queries related to all clinical trials in alignment with inspection readiness protocols.
- Met Interim Analysis Deliveries deadlines through thorough preparation of patient data.
- Monitored Independent Analysis Sessions to ensure compliance with analysis protocols.
- Facilitate site personnel training to enhance study trials and develop project specific manuals.
- Mentoring of peers as required for cross training.
- Perform Quality Control of Offsite Assessments/Blinded Reads.
- Facilitate client-specific activities in collaboration with Project Managers while delivering Imaging expertise to Core Lab Operations.
- Collaborate with clients, sites, site technical staff, and CRAs daily.
Research Assistant/Technician, Clinical Research
Children’s Hospital of Philadelphia
08.2001 - 11.2003
- Performed Imaging exams collecting growth measurements on assigned Bone studies.
- Managed and monitored tracking database of 2000 records of subject screening data collection.
- Ensured participant personal information met privacy compliance.
- Assisted in planning and attended community health fairs for the recruitment of study participants.
- Contacted potential participants through development of mail and flyer distribution.
- Interacted with families and hospital staff daily.
Research & Laboratory Assistant Co-op Internship
Wolverine Proctor & Schwartz Inc.
03.2000 - 08.2000
- Managed data collection and prepared product sample measurements for pilot testing to determine connective force drying parameters of commercial heating equipment.
- Managed and maintained database with analytical test data.
Education
Bachelor of Science - Nutrition And Food Sciences
Drexel University
Philadelphia, PA06.2001
Key Qualifications
- Over 23 years of experience working in Clinical Research.
- Clinical Research Therapeutic Areas include: Oncology/Respiratory/Musculoskeletal/Internal Medicine/Cardiac Safety/Cardiovascular/Vascular, Squamous Cell Carcinoma Head & Neck, Lung, Non-Small Cell Lung Carcinoma, Large B-Cell Lymphoma, Multiple Myeloma, Melanoma, Non-Hodgkin’s Lymphoma, Melanoma & Renal Cell Carcinoma/ (RSV) Respiratory Syncytial Virus in (HCT) Hematopoietic Cell Transplant Recipients,Tuberculosis, Rheumatoid Arthritis, Atopic Dermatitis,Thalassemia, Type II Diabetes, Obesity/Pre-Diabetes, Hyperlipidemia, Critical Limb Ischemia, Gastrointestinal, Immuno-Oncology, Immunology & Vaccines.
- Reporting: GCP, HIPPA, (SAE), Data Monitoring, Quality Control and Compliance, PHI redaction.
- US Federal Regulations Title 21 C.F.R Part 11 Compliance.
- Training: Mentoring, Process improvement, Quality improvement, Education and Training.
Computer Technical Skills
- Microsoft Outlook
- Microsoft Office
- Microsoft Word
- Excel
- PowerPoint
- PIER
- MIRA
- Adobe X Pro
- Inform
- Oracle Access Management
- Cisco WebEx
- Citrix
- Medidata Rave
- AGmednet
References
Available upon request.
Timeline
Imaging Specialist, Medical Imaging & Cardiac Safety Solutions
ICON Clinical Research
11.2003 - Current
Research Assistant/Technician, Clinical Research
Children’s Hospital of Philadelphia
08.2001 - 11.2003
Research & Laboratory Assistant Co-op Internship
Wolverine Proctor & Schwartz Inc.
03.2000 - 08.2000
Bachelor of Science - Nutrition And Food Sciences
Drexel University
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