Aleksandra Wawrzyniak
Westchester,NY
Summary
Committed and outcomes-oriented Clinical Research Manager with a proven track record of adherence to study protocols, standard operating procedures, and good clinical practices. Possesses strong organizational skills and a focused approach to task execution and project management. Demonstrates excellence in customer relationship management, consistently contributing to the successful achievement of company goals. A diligent professional with outstanding communication and planning abilities.
Overview
10
10
years of professional experience
Work History
Clinical Trial Manager
Tisch Cancer Center of New York
New York
04.2023 - Current
- Experience in Oncology research, specializing in First in Human Trials
- Lead study management for over 50 studies within first 2 months of joining
- Successfully initiated 9 trials within the first 8 months
- Implemented new workflows that resulted in 50% reduction in data and lab queries and increased Clinical Research Coordinator (CRC) productivity by 30%
- Improved feasibility of current Standard Operating Procedures (SOPs) and provided consultation on new processes and manuals
- Responsible for contract and budget negotiations with sponsors and vendors
- Managed team of Data Coordinators and Clinical Research Coordinators
- Ensured data quality by conducting regular reviews of data metrics and listings, monitoring protocol deviations, eligibility violations, dosing deviations, suspected non-compliance, and prepared for audits.
- Led regulatory study startup activities, including writing Informed Consent Forms (ICFs), submitting to Institutional Review Boards (IRBs), completing Financial Disclosure Forms (FDFs), 1572 forms, and other required documents.
- Managed feasibility assessments and provided oversight and input to clinical supplies forecasting
- Provided oversight for safety concerns, adverse events, and Serious Adverse Event (SAE) reporting.
Clinical Trial Manager
Tisch Research Center of New York/ IMSMP
New York
01.2020 - 12.2022
- Experience in various therapeutic areas including Stem Cell Transplants, Infusion (Rituxan, Ocrevus, Tysabri), Neurology, Rare Disease (Multiple sclerosis), Hematology, and Urology
- Manage and oversee clinical aspects of trials, including site feasibility, start-up activities, development of clinical plans and documents, subject enrollment, site engagement, and vendor management. Provide regular performance feedback to CEO
- Review study protocols, consent forms, and amendments to ensure internal and external consistency and compliance with FDA Good Clinical Practice (GCP) regulations.
- Provide training to Clinical Research Associates (CRAs) on study protocols and objectives.
- Monitor and track subjects' compliance throughout trial, addressing day-to-day subject or study issues and escalating when necessary.
- Conduct ongoing recruitment activities for challenging indications with low enrollment rates.
- Negotiate contracts, create billing, and reconcile procedures, treatments, and vendor expenses.
- Support and oversee various activities including resourcing, regulatory documentation, data cleaning, and study close-out
- Manage multiple projects/studies with strict timelines, including Phase I, Phase I Extension, Phase II, Expanded Access, Compassionate Care, and Bone Marrow programs at both CRO and Sponsor levels.
- Develop, drive, and manage study timelines, monitoring schedules, and all monitoring activities.
- Ensure timely invoicing for clinical trial accounts.
- Assist in creating, editing, and finalizing study-related documents.
- Write and review FDA, Institutional Review Board (IRB), and Biogen data and extension reports.
- Ensure compliance with local, state, and federal healthcare regulations, including Medicare and Medicaid requirements, HIPAA, and OSHA
- Design and execute clinical trial protocols in collaborative environment with rapidly shifting priorities.
- Review monitor visit reports and address safety concerns.
- Serve as main point of contact for patients regarding trial qualification, issues, and participation.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
Clinical Trial Coordinator
Tisch Research Center of New York/ IMSMP
New York
03.2018 - 01.2020
- Oversee and coordinate all medical work-ups, treatments, and procedures for bone marrow and stem cell patients.
- Collaborate in review, development, and implementation of policies, protocols, and practice guidelines to ensure adherence to federal government and institutional regulations.
- Identify, establish, and foster relationships with key clinical and non-clinical decision-makers.
- Provide comprehensive education to patients regarding their treatment, recovery, and post-transplant care.
- Efficiently organize and collect pre-transplant, intra-transplant, and post-transplant clinical data.
- Maintained compliance with study protocols, ensuring accurate documentation of all study-related activities.
- Conducted regular site visits to monitor progress, address any issues, and maintain open lines of communication with investigators.
- Managed multiple projects concurrently without compromising quality or attention to detail.
- Supported efforts to improve operational efficiency within the clinical trials department through process improvements and best practice sharing.
Administrative Assistant
IMSMP
New York
02.2017 - 03.2018
- Provide administrative assistance directly to the CEO
- Optimize calendars for more than 500 patients
- Verify insurance eligibility and authenticate specific medical procedures to ensure proper billing procedures
- Handle payment processing and record charges on patient accounts
- Manage incoming telephone calls and address patient requests.
- Supported executive staff through scheduling meetings, coordinating travel arrangements, and preparing crucial documents.
- Improved document organization with thorough file maintenance, archiving outdated records as necessary for efficient retrieval when needed.
- Developed strategies to streamline and improve office procedures.
Media Billing Coordinator
Re:Sources- Starcom Publicis Group
Queens, NY
08.2016 - 02.2017
- Conducted daily reconciliations and clearances for client invoices, including issuance of drafts, live billing, and reversal billing.
- Resolved discrepancies in vendor invoices and initiated daily invoice register.
- Generated reports and contributed to collection efforts.
- Formatted media reports and delivered presentations to clients.
- Collaborated with payables team to generate hard copies of billing with vendor backups.
- Managed multimillion-dollar account activity.
- Worked in conjunction with national and international teams to facilitate client billing and pre-billing processes.
Administrative Assistant/ Accountant
Hoops Plus
Westchester
07.2014 - 09.2015
- Offered administrative assistance to the President of the company.
- Analyzed and forecasted customer behaviors and trends.
- Investigated and resolved discrepancies in billing and invoices.
- Tracked client payments, contacting those with overdue payments directly.
- Generated invoices, quotes, and purchase orders.
- Calculated sales tax reports and compiled sales reports.
- Disclosed and negotiated prices with vendors.
- Conducted bank reconciliations for various accounts.
- Enhanced office efficiency by streamlining administrative processes and implementing organizational systems.
- Ensured accurate record-keeping with diligent data entry and database management for vital company information.
- Delivered excellent customer service through prompt responses to client inquiries, addressing concerns effectively, and building strong relationships.
Education
B.B.A. Graduate - International Business
Berkeley College
New York, NY12.2016
Associates of Applied Science Degree - Fashion Merchandising
Westchester Community College
Valhalla, NY05.2015
International Relations and Business -
Adam Mickiewicz University
Poland05.2012
Skills
- Research/Trial oversight experience, EDC, TMF
- Understanding of GCP, ICH and regulatory requirements
- Microsoft Office
- Finance: MediaBank-OX, Spectra-DDS System, Lion Box
- Medical: Medics Elite, Medics Premier, DocAssist, OpenClinica, EMR, Epic, OnCore, RedCap
- Audit Preparation
- Patient Recruitment
- Document Review
- Study Design
- Training and Mentoring
- Project Management
- Risk Assessment
- Analytical Skills
- Interpersonal Skills
Timeline
Clinical Trial Manager
Tisch Cancer Center of New York
04.2023 - Current
Clinical Trial Manager
Tisch Research Center of New York/ IMSMP
01.2020 - 12.2022
Clinical Trial Coordinator
Tisch Research Center of New York/ IMSMP
03.2018 - 01.2020
Administrative Assistant
IMSMP
02.2017 - 03.2018
Media Billing Coordinator
Re:Sources- Starcom Publicis Group
08.2016 - 02.2017
Administrative Assistant/ Accountant
Hoops Plus
07.2014 - 09.2015
B.B.A. Graduate - International Business
Berkeley College
Associates of Applied Science Degree - Fashion Merchandising
Westchester Community College
International Relations and Business -
Adam Mickiewicz University