Jessica Luvianos
Winthrop Harbor,IL
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
5
5
years of professional experience
Work History
Central Study Coordinator
ProPharma Group
06.2025 - Current
- Serve as a point of contact for a day-to-day Site communications, document submissions an activity coordination
- Support pre-screening, screening and recruitment activities
- Responsible fo subject re-consenting, acquiring medical records, conducting protocol activites as directed by the Principal Investigator
- Perform data-entry, evaluate and respond to system queries, monitor clinical databases
- Establish and maintain timely Site communication
- Maintain documentation complying with IRB/FDA policies
- Assist with study closeout
Senior GoClinical Project Coordinator
ProPharma Group
08.2022 - Current
- Organize and lead Sponsor/CRO and Vendor teleconferences as assigned.
- Provide Guidance to Project Coordinators and Clinicians assigned to projects.
- Deliver protocol specific training and applicable amendment training to Clinicians, Clinician Manager and Project Coordinators for assigned studies.
- Communicate to all study teams and management of study closeout for assigned studies.
- Oversee and manage the creation, maintenance, and updates of study details in CTMS and GoClinical, including, but not limited to, Sponsor, Study, Site, and related contact information, subjects, visits, issue tracking, and all visit related details.
- Serve as a point of contact for day-to-day Site and Clinician communication, document submissions and activity coordination.
- Assist in the creation and development of study documents and training material as requested by the Project Manager
- Oversee and complete site setup including DCV introduction and training.
- Receive, track, review, manage, and distribute source documents from decentralized visits.
- Attend and keep minutes for all assigned Kick Off Meetings, internal handoffs, vendor teleconferences and Sponsor teleconferences.
- Establish and maintain timely Sponsor, CRO, Site, and Central Lab communication as assigned by the Project Manager.
- Oversee and support activities surrounding Decentralized Visits and Clinician activities, including, but not limited to, visit scheduling, courier booking, sample collection and delivery coordination.
- Track and report metrics as directed by Project Manager.
- Comply with Quality Management System and applicable SOPs.
- Escalate risk and risk mitigation plans for all study related issues to Associate Director, DCT or designee.
- Oversee and manage small, two low-risk DCT studies
GoClinical Project Coordinator
ProPharma Group
08.2022 - 04.2024
- Created, maintained, and updated study details in CTMS and GoClinical. Including: Sponsor, Study, Site, and all related contact information, subjects, visits, issue tracking and all visit related details.
- Point of Contact for day-to-day Site communications, document submissions and activity coordination.
- Inventory management, oversight and coordination of shipping and tracking logistics in the field and within CTMS.
- Assisted Project Manager with creation and development of study documents and training materials as requested.
- Completed site setup including decentralized visit introduction and training.
- Received, tracked, reviewed, managed and distributed source documents from decentralized visits.
- Attended and kept minutes during Kick off Meetings, internal handoffs, vendor teleconferences and Sponsor teleconferences.
- Established and maintained timely Sponsor, CRO, Site and central lab communication as assigned by Project Manager.
- Supported activity surrounding decentralized visits and Clinician activities including visit scheduling, courier booking, and sample collection and delivery coordination.
- Tracking and metric reporting as directed by Project Manager.
- Assisted with audits of CTMS and GoClinical as directed by Project Manager.
- Assisted Project Manager with three study closeouts including reconciliation of returned equipment from the field, reconciliation of CTMS and GoClinical.
Senior Clinical Trial Assistant
Accellacare
04.2021 - 08.2022
- Administrated, coordinated and managemed delegated study activities for fifteen active studies.
- Proactive communication with clinical service providers
- Reviewed all homecare documentation in accordance with GCP and study specific requirements within a target turnaround timeframe
- Maintained documents and Central Study Files in accordance with GCP and study specific requirements
- Assisted with internal audits and study closeout activities
- Assisted with Sponsor and Vendor reporting
- Ran bi-weekly metric reports to identify status of homecare worksheets.
- Compliance with ICH/GCP, IATA, HIPAA, and other appropriate regulations.
- Created Note to Files and Data Clarification Forms for Clinical Study Managers
- Scheduled drug deliveries via World Courier for one study protocol
- Updated study drug-pick up and deliveries as necessary for particular homecare visit
- Entered visit schedule dates into CRM database
- Entered clinician trainings in the CRM database as requested by Clinical Study Managers
- Entered site introductions in the CRM database as requested by Clinical Study Managers
Project Assistant Documentation Management
Accellacare
02.2020 - 04.2021
- Reviewed seven study protocols for closeout procedures including verifying clinician training certificates, Delegation of Authority, updated and signed Curriculum Vitae, active nursing license and interview forms.
- Quality checks of homecare worksheets for correctness and accuracy.
- Proactive communication with Clinical Study Managers, internal and external teams to finalize closure of study including: Outsourcing, Accounts Payable, Data and Documentation Specialist and international teams.
- Created quality check templates. Created and sent three study closeout notifications to sponsor regarding three distinct study protocols. Created Note to Files and Data Clarification forms for Clinical Study Managers.
- Assisted Clinical Study Managers with queries from Monitors, Sites and Sponsors.
- Assisted with internal audits and customer audits as needed.
- Completed the review of three study protocols for closeout reconciliation activities.
- Maintained a long-term archival record in accordance with GCP and study specific requirements. Reviewed and monitored secure email and eFax for documentation and distributed to appropriate departments as required.
- Responsible for twenty-one study protocol metrics and distributed to Clinical Study Managers at specific intervals.
- Developed a report for incomplete administrative worksheets. Created and sent active site visits report, pending administrative worksheet report and specific study protocol reports.
- Sent approved homecare worksheets and Raw Data to site and Sponsor. Sent updated clinician documentation to site and clinician when requested.
- Entered administrative worksheets into CRM database.
- Trained on and built specific study protocol homecare visit kits when requested.
- Trained Assistant Study Managers on sending clinician documents to site and clinicians
- Trained two Data and Documentation Specialist on their job description.
Education
Bachelor of Science - Biology
Saint Xavier University
Chicago, IL05-2019
Skills
- Clinical data management
- Informed consent process
- Patient recruitment
- Site monitoring
- ICH/GCP
- SOP understanding
- Study protocols
- Participant recruitment
- Teamwork and collaboration
- Problem-solving
- Time management
- Multitasking
- Leadership skills
- Excellent communication
- Organizational skills
- Attention to detail
- Adaptability and flexibility
- Organizational and multitasking
- Documentation management
- Clinical research
- Study closeout
- Good clinical practice
- Informed consent
- Schedule coordination
- Research sops understanding
- Software: Microsoft, Zelta, EDC, Cloudbyz
Therapeutic Area(s) of Expertise
- Oncology
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Central Study Coordinator
ProPharma Group
06.2025 - Current
Senior GoClinical Project Coordinator
ProPharma Group
08.2022 - Current
GoClinical Project Coordinator
ProPharma Group
08.2022 - 04.2024
Senior Clinical Trial Assistant
Accellacare
04.2021 - 08.2022
Project Assistant Documentation Management
Accellacare
02.2020 - 04.2021
Bachelor of Science - Biology
Saint Xavier University
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