Mia Muchnick
Exton,PA
Summary
Experienced clinical research professional specializing in project management support. An adaptable and detail-oriented team player seeking to develop and amass new techniques, and hone in on existing skills.
Overview
3
3
years of professional experience
Work History
Senior Clinical Trial Assistant
Marinus Pharmaceuticals
04.2023 - 05.2024
- Supports the clinical study team members with accurately updating and maintaining the clinical trial management system (CTMS), archiving trial data, and documents.
- Assists in budget preparation by analyzing resource requirements while maintaining cost efficiency.
- Supervision of all study parameters, including clinical study startup activities, supplies preparation, enrollment, data collection, and close out.
- Oversees management and reconciliation of the Trial Master File (TMF) for inspection readiness including proficiency in QC review and issue resolution.
- Responsible for creation, maintenance, and distribution of study-level reports, meeting agenda and minutes, and excel trackers for clinical management usage.
- Manages and provides oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established timelines.
- Facilitates in managing and developing study-specific materials, such as informed consent forms, study plans, and subject recruitment materials, to ensure data integrity and regulatory compliance.
- Conducts regular quarterly audits of three study trial master files to ensure completeness, accuracy, and compliance with regulations.
- Participates in the selection of appropriate clinical sites by evaluating potential locations and assessing capacity for successful trial outcomes.
Senior Global Clinical Trial Assistant
ICON
11.2021 - 04.2023
- Supported operational aspects of all GCO managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, report and closure).
- Worked in support of the trial team, including the GCO Program Leader, GCO Trial Leader, and Clinical Trial manager.
- Services provided included tracker trial progress towards planned milestones, as well as related progress analysis and follow-up.
- Tracked the trial and country budgets and supported invoice reconciliation.
- Supported protocol and country feasibility, site selection, and vendor set-up.
- Performed trial specific system set-up and access management, system data entry and was responsible for internal external meeting planning, coordination, outcome documentation, and related follow-up.
- Oversaw electronic TMF document management and quality.
- Contributed to clinical trial execution by coordinating with cross-functional teams and ensuring regulatory compliance.
Clinical Project Assistant I
Clinlogix, LLC
02.2021 - 11.2021
- Assisted with updating and maintaining study relevant documents.
- Supported clinical sites with designated project communications, correspondence, and associated documentation.
- Collaborated with Project Managers, CRAs, and Sponsors with development, preparation, handling and distribution of Study Supplies (ie. relevant study binders and packets) and manage distribution status per study.
- Set up study files and maintain records in the Clinical Trial Management Systems (TMF, CTMs, etc.)
- Distributed, requested, collected, and reviewed site regulatory documents for the applicable phase of the study (Start Up, Enrollment, Follow-up, Maintenance, etc.)
- Aided study team on ensuring sites' compliance to study protocol, timeline and regulatory guidelines.
- Created and completed informed consent form (ICF) checklists for applicable sites and studies as needed.
- Maintained and tracked all study personnel's up-to-date training status and information.
- Facilitated collection and review of safety source documents provided by sites.
- Supported sites & study team with study related documents/imaging uploads.
Education
Bachelor of Arts - Global Studies
Temple University
Philadelphia12.2019
Skills
- CRO oversight and management on outsourced studies
- Proficient in small team management
- Early and Late phase trials
- Reviewing and approving ICF drafts and revisions to ensure local MOH/EC qualifications are met
- Central and local IRB submissions
- Experienced in rescue studies and portfolio acquisitions
- Has taken part in external audits and audit query responses
- In-office and online TMF reconciliation
- Inspection readiness
- Creation of meeting agenda drafts and meeting minutes
- Vendor Supply Management
- Oversight and management of Emergency Investigation New Drug (EIND) application process
- Standard Operational Procedure (SOP) and Training Plan creation process
- Electronic Data Capture
Additional Trainings
- NIDA GCP Training, 02/23/21, Clinlogix LLC
- Clinical Pathways Good Clinical Practice Training (GCP): ICH E6 (R2), 10/19/23, Marinus Pharmaceuticals INC.
System Proficiencies
- Veeva Vault
- SimpleTrials
- LabCorp LabLink+ and Xcellerate
- WordPress
- Medidata
- DrugDev Enterprise Investigator Portal
- Signant Health Randomization and Trial Supply
- IMedNet
- IBM eCOS
- Zelta EDC
- Microsoft Suite
- BOX Collaboration
- Cysco Jabber
- Zoom
- Webex
Timeline
Senior Clinical Trial Assistant
Marinus Pharmaceuticals
04.2023 - 05.2024
Senior Global Clinical Trial Assistant
ICON
11.2021 - 04.2023
Clinical Project Assistant I
Clinlogix, LLC
02.2021 - 11.2021
Bachelor of Arts - Global Studies
Temple University
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