Madeline Gasparo
Johnson & Johnson: Cerenovus
Pasadena,CA
1
Certification
8
years of professional experience
Detail-oriented and highly organized Clinical Research Professional with 5 years of experience in clinical trial operations, essential document management, trial compliance, and TMF quality control. Proficient in OneCTMS, vTMF, and VIPER, with a strong track record of maintaining audit and inspection readiness in accordance with ICH E6 GCP guidelines. Skilled in visit coordination, invoice management, and cross-functional communication, with a proven ability to prioritize and manage multiple concurrent studies within strict timelines.
Work History
Clinical Study Administrator
3 Years- Facilitates communication and alignment across clinical, regulatory, and R&D teams to streamline trial execution and ensure compliance with GCP, GDP, and FDA guidelines.
- Maintained device-specific TMF documentation including device accountability logs, deficiency reports, and IDE correspondence, achieving 100% inspection-ready status.
- Coordinated site-level device training and certification prior to activation, ensuring investigators met protocol-specific device handling requirements
- Served as a central point of contact for site visit coordination, managed cross-functional communications, and captured and filed all visit-related documentation accurately.
- Maintained TMF for 28 active clinical sites with 100% audit-ready compliance.
- Tracks and obtains IRB Approvals and Submissions, in VTMF, and Medidata Rave.
- Manage high-volume study inboxes and routing correspondence to appropriate team members to maintain organized, timely, and compliant communication records.
- Maintain and quality control essential trial documents within OneCTMS and VTMF ensuring TMF completeness and in accordance with ICH E6 GCP guidelines.
- Track and manage all essential documents throughout the trial lifecycle, identifying and resolving deficiencies proactively to support audit-ready status at all times.
- Proactively creates and generates system reports within VTMF, VIPER, and OneCTMS.
- Created quarterly invoices for Japan Site and SMO, ensuring accurate documentation and timely updates.
- Acted as primary contact for Japan team regarding quarterly invoices, facilitating clear communication and prompt responses.
- Creates and maintains study trackers.
- Act as sole liaison for Japan team visit invoicing operations, overseeing invoice creation and maintaining meticulous tracking to support financial accuracy and compliance across the trial.
- Managed version Control for Clinical Trial Documentation.
Research Nursing Project Coordinator
2 Years 1 Month- Maintenance of the research nursing project electronic files, ensuring GCP, SOP compliance and audit readiness.
- Quality check of source documents and other paperwork generated by RNs during a visit, ensuring documents are in accordance with ICH-GCP.
- Communicating with research nurses to facilitate corrections and arranging for these documents to be returned to sites within the required timeframe.
- Maintains effective communications between Illingworth and the RNs, clients, sites, vendors, which included preparation of agendas and minutes, updating client project trackers, and presenting visit metrics during client meetings.
- Provided mentoring to incoming RNPCs.
- Assisted the Managers of Project Support Services with identifying areas for further training and development of the team and contributed to development of related training materials.
- Took on Project Management tasks at a project level where delegated. Attends and leads client and sponsor meetings and presents updates in a timely and knowledgeable manner.
- Managed 5-8 sites at a time, ensuring GCP and Protocol Adherence.
Chiropractic Rehab Unit Intern
4 Months- Kept physical files and digitized records organized for easy updating and retrieval by authorized team members
- Worked closely with patients, averaging 7-10 patients at a time, by stretching and providing them with rehabilitation techniques to promote health and well-being.
- Communicated with Physicians and Physical Therapists to determine what module each patient should be working with at each stage of their rehabilitation.
- Took on management duties for the rehab unit, and educated patients on benefits of assigned rehabilitation modules.
Education
Bachelor of Science - Kinesiology
- Kinesiology with a concentration in Clinical Exercise Science
- Relevant Coursework: Clinical Exercise Science, Biomechanics, Human Anatomy and Physiology, Research Methods, Biostatistics, Physics
Skills
Time management
Problem-solving
ICH E6 Good Clinical Practice (GCP)
Trial Master File (TMF) Management
Regulatory Compliance
EDC/OneCTMS
Visit Coordination & Logistics
Invoice creating and tracking
Study Start-Up
Study Close-Out
Microsoft Excel
Medidata Rave
Affiliations
- ACRP Member
- Clinical Research Fastrack
Certification
Clinical Research Fastrack Certification
- Knowledge of ICH GCP Guidelines on how to administer clinical trials
- Protecting the rights of the patient, and the role of the IRB and HIPPA
- FDA regulations 21 CFR Parts (11, 50, 54, 56) and the content within a Regulatory Binder
- Learned how to dissect a protocol and the financial aspects of running a clinical trial
- GDP while adhering to ALCOA-C principles
- Investigator, CRC, CRA responsibilities before, during, and after a trial
- Recruitment and retention of Clinical Research subjects
- The informed consent process and how to document ICF
- Knowledge of data management systems and clinical trial operations such as electronic case report forms and the flow of a study
- How Monitoring, Quality Assurance, and Inspections operate in accordance with a trial
Timeline
Clinical Study Administrator
Johnson & Johnson: Cerenovus
08.2023 - CurrentRead More
Research Nursing Project Coordinator
Illingworth Research Group
01.2021 - 02.2023Read More
Chiropractic Rehab Unit Intern
American Physical Medicine
08.2018 - 12.2018Read More
Arizona State University
Bachelor of Science from Kinesiology
Read More
Therapeutic Experience
- Oncology: Lung Cancer, Mesothelin Expressing Cancers
- Rare Diseases: ALS, Hunter Syndrome
- Other: Anemia, COVID-19, Ischemic Stroke