Morgan Supczenski
Leonard,TX
Summary
Multi-talented Biotechnology/Pharmaceutical industry professional proficient in handling PII, FDA regulatory and compliance procedures, IRB/EC submission documents, Data management, Clinical Study Reports and SIV/IM attendance and training materials. Managed and maintained over 50 clinical trials ranging from Phases I-V in therapeutic areas including ONCOLOGY, NEUROLOGY, HEMATOLOGY, RARE DISEASE, and VACCINES. Extensive knowledge in vitro diagnostics (IVDs) and medical devices (MDs). Clinical Research Coordinator I/II experience in complying with study protocols, standard operating procedures and good clinical practices (GCP) from study concept to close out. I am prepared to offer over 10 years' experience in the field and take on a fast-paced position. Highly motivated with desire to take on new challenges. I am a hardworking employee with customer service experience, administrative management, patient retention, monitoring visit reports (MRVs) and electronic Trial Master Files (eTMFs) background. Committed job seeker with a history of meeting company needs with consistent and organized practices.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Outcomes and Analytics Coordinator I
Baylor Scott And White Heart Hospital
04.2024 - Current
- Entering data within a number of clinical registries such as GWTG:CAD, NCDR, ARMUS.
- Registry Site Manager for Get With The Guidelines- GWTG:CAD for all 3 heart hospitals in DFW region. (Plano, McKinney and Denton). Assisted with Cath PCI registry data reporting.
- Entered data, generated reports, and produced tracking documents and PowerPoints.
- Managed scorecards, benchmarks, and projected timelines for successful completion.
- Presented data for most meetings within a hospital setting and national.
- Coordinated cross-functional teams, resulting in seamless project execution and enhanced outcomes.
Associate Project Manager
Becton Dickinson
12.2023 - 01.2024
- Developed and implemented project plans to ensure timely completion of clinical trials involving ONCOLOY research.
- Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
- Assessed study progress and identified potential risks or delays in order to develop strategies for mitigation.
- Maintained accurate records of all repairs, calibrations and preventive maintenance activities involving medial devices.
- Collaborated with Principal Investigators, Sponsors and Clinical Research Coordinators to ensure accuracy of clinical trial data.
- Conducted site selection visits to assess suitability for oncology trials.
- Drafted study documents including protocols, informed consent forms, case report forms and other regulatory documents.
Clinical Trial Project Manager
Scout Clinical
03.2021 - 09.2023
- Managed and maintained over 50+ Clinical Trials contracted with CROs/Sponsors (including but not limited too; Pfizer, Moderna, Agios, Genentech, ICON, Merck, AstraZeneca, Thermo Fisher, IQVIA, PPD etc.) from concept to study close out in accordance with GCP and ICH guidelines in therapeutic areas including ONCOLGOY, NEUROLOGY, HEMATOLOGY, RARE DISEASE, and VACCINES.
- Ensured compliance with FDA regulations, ICH and GCP guidelines for all clinical trials studies.
- Created and managed clinical trial databases, including data entry of source documents into the database.
- Created and managed site data information within GDPR company interface.
- Created and doctored patient and site facing documentation to be submitted to IRB/EC.
- Developed and maintained trial master files in accordance with GCP and ICH guidelines.
- Created detailed project plans, using Gantt charts, Waterfall and other tools.
- Conducted regular meetings with team members to ensure timely delivery of projects.
- Conducted regular meetings with CRO/Sponsors to ensure study accuracy and patient retention.
- Attending Virtual and In-Person SIV/IMs as requested.
- Developed and implemented quality assurance procedures for all projects working with regulatory and compliance.
- Identified risks associated with projects and took proactive measures to mitigate them.
- Conducted monthly audits on all clinical trial studies contracted to ensure study remained within budget.
Clinical Trial Department Manager
Scout Clinical
01.2021 - 09.2023
- Created, trained and managed department employees on the clinical trial databases, including data entry of source documents into the GDPR and GCP compliance interface.
- Performed reconciliation audits between source documents and database entries to ensure accuracy of information with monthly statements and reporting for each Clinical Trial Study.
- Worked with regulatory and compliance to doctor and create patient and site facing documentation for IRB/EC submission.
- Provided support and guidance to Clinical Research Associates on site monitoring activities as needed and implemented training on company SOPs.
- Organized, coordinated, and hired new employees for CTA position within the company.
- Managed and maintained department payroll and PTO.
- Implemented and developed social media marketing and working with business development for parent company.
- Developed training materials, including manuals, guides and handouts.
- Provided coaching and mentorship programs for staff members.
Clinical Trial Assistant
Scout Clinical
01.2020 - 03.2021
- Conducted site visits to monitor study progress, assess compliance with protocol, and review source documentation.
- Collaborated with internal teams on project timelines and deliverables.
- Tracked subject enrollment status, screening results, adverse events, concomitant medications.
- Assisted in the development of clinical trial protocols, case report forms, and other study documents.
- Participated in Investigator Meetings to discuss study updates and issues.
- Performed data entry into electronic databases for tracking purposes.
- Provided support for all aspects of the clinical trial process including recruitment, data collection, and closeout activities.
- Maintained regulatory documents such as informed consent forms and investigator brochures.
Clinical Research Coordinator I/II
HRI/ Hassman Research Intitution
02.2015 - 12.2019
- Developed and maintained study timelines for multiple studies.
- Organized and conducted meetings with internal stakeholders to discuss progress of studies.
- Assisted in the creation of protocols, case report forms, informed consent documents, and other study related materials.
- Ensured compliance with Good Clinical Practices guidelines throughout all stages of clinical trials.
- Trained new team members on the principles of Good Clinical Practice and ICH regulations.
- Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
- Reviewed source documentation for accuracy of data entered into eCRFs.
- Collaborated with internal departments such as Regulatory Affairs, Data Management, and Biostatistics to ensure timely completion of studies.
- Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
Education
Master of Science - Early Childhood Education
Rutgers, The State University of New Jersey
Camden, NJ06.2015
Bachelor of Science - Early Childhood Education
Gloucester County Community College
05.2011
Skills
- Protocol Development and Review
- Regulatory Compliance
- Participant Recruitment and Enrollment/Retention
- Data Collection Management
- Trial Oversight and Budget Management
- Quality Assurance
- Site Training and Education
- Registry Site Management
- Monitoring and Auditing
- IRB/EC Documentation and Reporting
- Contract Research Organization (CROs)
- Good Clinical Practice (GCP)
- Site Selection
- Data entry
Accomplishments
- Hired to organize and customize three positions within Scout Clinical (Clinical Trial Associate).
- Promoted to create Associate Project Management position within Scout Clinical.
- Promoted to created Director of Clinical Trial Associates within Scout Clinical ending my tenure.
- CRO/Sponsor recognition for maintaining and uploading company SOP and meeting contracted deadlines.
- Recognized as an outstanding employee for each quarter at Scout Clinical resulting in quarterly 4% bonus.
- Improved Project Delivery Management by working with Business Development and Marketing to improve and retain patient retention, resulting in overall increase in customer satisfaction and cost efficiency.
- Created all Work Instructions (WIs) for all three departments created.
Certification
- CURRENTLY WORKING TOWARDS- CPHQ Cert
- Good Clinical Practice (GCP) Human Research Group 7
- GDPR Training
Timeline
Quality Outcomes and Analytics Coordinator I
Baylor Scott And White Heart Hospital
04.2024 - Current
Associate Project Manager
Becton Dickinson
12.2023 - 01.2024
Clinical Trial Project Manager
Scout Clinical
03.2021 - 09.2023
Clinical Trial Department Manager
Scout Clinical
01.2021 - 09.2023
Clinical Trial Assistant
Scout Clinical
01.2020 - 03.2021
Clinical Research Coordinator I/II
HRI/ Hassman Research Intitution
02.2015 - 12.2019
Master of Science - Early Childhood Education
Rutgers, The State University of New Jersey
Bachelor of Science - Early Childhood Education
Gloucester County Community College
- CURRENTLY WORKING TOWARDS- CPHQ Cert
- Good Clinical Practice (GCP) Human Research Group 7
- GDPR Training
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