Morgan Supczenski
Whitewright,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. 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, 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
9
9
years of professional experience
1
1
Certification
Work History
Associate Project Manager
Becton Dickinson
Franklin Lakes, NJ
12.2023 - 01.2024
- Developed and implemented project plans to ensure timely completion of clinical trials.
- 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
Dallas, TX
03.2021 - 09.2023
- Managed and maintained over 50+ Clinical Trials contracted with CROs/Sponsors 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
Dallas, Texas
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
Dallas, TX
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
Marlton, NJ
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
Sewell, NJ05.2011
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
- Planning and Coordination
- Monitoring and Auditing
- Ethical Considerations
- IRB/EC Documentation and Reporting
- Vendor Management
- Contract Research Organization (CROs)
- Good Clinical Practice (GCP)
- Site Selection
- Resource Allocation
- Cross-functional Collaboration
- Risk Management
- Strategic Planning
Accomplishments
- Promoted and praised from Clinical Trial Associate due excellent work ethic and promising future company goal accomplishments that achieved Clinical Project Manager position.
- Promoted and praised from Clinical Trial Project Manager due expressing managerial and administrative skills in hiring, managing and maintaining an developing a new department of Clinical Trial Associates after being originally hired to create the Clinical Trial Associate position within Scout Clinical that achieved in the Clinical Trial Associates Department Manager.
- Consistently maintained high customer satisfaction ratings.
- Recognized as Employee of Each Quarter for outstanding performance and team contributions.
- Promoted from Clinical Trial Associate to Clinical Trial Project Manager, to Clinical Trial Associate Department Manager in less than 24-months.
- 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.
Languages
English
Full Professional
Certification
- Good Clinical Practice (GCP) Human Research Group 7
- GDPR Training
Timeline
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
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