Experience

Replimune

• United States
• Biotechnology Research
• 100 - 200 Employee

• Clinical Document Specialist

  • Nov 2022 - Present

  Woburn, Massachusetts, United States - Responsible for set-up, maintenance, document quality control (QC) review, completion and archiving of eTMF documents for Replimune trials - Responsible for processing eTMF documentation and performing quality control (QC) review in accordance with Replimune standard operating procedures (SOPs), ICH-GCP guidelines, eTMF reference model and study specific eTMF Plans - Ensure eTMF documents meet good documentation practices (GDP) by confirming ALCOA+ (Attributable, Legible… Show more - Responsible for set-up, maintenance, document quality control (QC) review, completion and archiving of eTMF documents for Replimune trials - Responsible for processing eTMF documentation and performing quality control (QC) review in accordance with Replimune standard operating procedures (SOPs), ICH-GCP guidelines, eTMF reference model and study specific eTMF Plans - Ensure eTMF documents meet good documentation practices (GDP) by confirming ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate and Complete) principles - Remediates issues and/or discrepancies identified with eTMF content, directly with the Replimune cross-functional teams and Contract Research Organizations (CROs) as applicable - Play a critical role in eTMF document management activities in accordance with eTMF Operations processes and procedures to ensure the eTMF is audit and inspection ready - Collaborate cross-functionally across the organization, ensuring that all documents necessary to provide an accurate reconstruction of the trial are identified and collected - Perform comprehensive completeness reviews inclusive of cross-referencing, ensuring documentation is filed according to the Replimune eTMF Index and eTMF Plan - Effectively manage documents residing in various locations with different filing structures - Ensure the Replimune eTMF is always ‘inspection ready’ and documents are filed contemporaneously, in accordance with established timelines - Ensure documents which fail quality review are effectively remediated and indicated as resolved/closed - Represent eTMF Operations at study team meetings, participate in collaborative efforts, and play an important cross-functional role in eTMF document retrieval and management - Provide support to eTMF Operations during audits and/or regulatory inspections - Identify trends and escalate concerns to eTMF Sr - Adhere to eTMF SOPs, KPIs, and relevant eTMF process-supporting guidance Show less



INOVIO Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Associate Clinical Scientist

  • Aug 2021 - Aug 2022

  Plymouth Meeting, Pennsylvania, United States - Tasked with supporting all aspects of the planning, execution, and administrative activities associated with the conduct of clinical trials as assigned within Clinical Operations at Inovio - Implementation and maintenance of project processes and tracking systems - Generation and distribution of status reports to management and team members - Supports the development, collection, review, tracking, maintenance, and archiving of essential study documents in the Trial Master File… Show more - Tasked with supporting all aspects of the planning, execution, and administrative activities associated with the conduct of clinical trials as assigned within Clinical Operations at Inovio - Implementation and maintenance of project processes and tracking systems - Generation and distribution of status reports to management and team members - Supports the development, collection, review, tracking, maintenance, and archiving of essential study documents in the Trial Master File, including: informed consent forms, clinical trial outlines, monitoring plans, synopses, IND annual updates, clinical summaries, protocols and amendments - Primary point of contact of leadership and oversight for assigned study - Therapeutic expertise managing Oncology studies - Supports the oversight of data quality including regular review of data metrics, protocol deviations, eligibility violations, dosing discrepancies, and suspected serious non-compliance by sites - Supports project lead in managing escalated issues related to study conduct, quality, timelines, and budgets, developing and implementing appropriate actions to address issues - Supports management and oversight of study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, trial master file, and study drug accountability - Management and oversight of CRO and other third party vendor performance to ensure alignment with scope of work will meet project timeline goals

• Clinical Trial Associate

  • Jan 2020 - Aug 2021

  United States • Assist with filing and maintaining study files, investigator files, and study plans. • Work with Clinical Project Lead to collect relevant study information on timelines, progress and resources. • Assist in the development, review, and tracking of clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents. • Maintain project processes, tracking systems and other utilized study systems. Generate and… Show more • Assist with filing and maintaining study files, investigator files, and study plans. • Work with Clinical Project Lead to collect relevant study information on timelines, progress and resources. • Assist in the development, review, and tracking of clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents. • Maintain project processes, tracking systems and other utilized study systems. Generate and distribute status reports to management and other clinical team members. • Assist with management of study timelines and study progress. Undertake defined responsibilities delegated by the CPL or designee. • Assist the CPL or designee in the management and tracking of patient visits, clinical supplies, including drug, devices, lab kits, and lab samples, etc. • Coordinate and support clinical team, consultant and vendor meetings. • Assess meeting requirements and plan appropriately (e.g., arrange meeting room, schedules teleconference, distributes meeting agenda, prepares and distributes meeting minutes, etc.) • Complete assigned tasks in accordance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial management. • Provide progress updates and summaries to CPL. • Communicate study-related information to investigators and study staff as delegated by the CPL. • Plan and/or participate in conduct of Investigator Meetings. • Upload and manage documents to Trial Master File (TMF) and electronic TMF platforms • Manage team members’ study specific training. • Manage study specific SOPs. • Other tasks may be assigned based on skill sets and business needs.



WiFi Map

• United States
• Technology, Information and Internet
• 1 - 100 Employee

• Software QA Engineer

  • Jun 2020 - Jun 2022

  Remote - Excellent understanding of Software Development Life Cycle (SDLC) and Software Testing Methodology - Responsible for compatibility testing on a variety of devices and platforms - Performing smoke and regression testing to inspect critical functionalities and reliability of the system - Analyzing user stories to identify potential testing areas - Reporting defects in Jira and monitoring defect status - Participating in design reviews and providing input on requirements, product… Show more - Excellent understanding of Software Development Life Cycle (SDLC) and Software Testing Methodology - Responsible for compatibility testing on a variety of devices and platforms - Performing smoke and regression testing to inspect critical functionalities and reliability of the system - Analyzing user stories to identify potential testing areas - Reporting defects in Jira and monitoring defect status - Participating in design reviews and providing input on requirements, product design, and suggesting improvements - Found a major security flaw and escalated to the engineering manager to address the issue Show less



Penn Medicine, University of Pennsylvania Health System

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Technician

  • Dec 2018 - 2019

  Philadelphia, Pennsylvania, United States - Investigates 400+ human-based clinical research trials according to IRB standards, coordinating with PIs and study teams to ensure protocol guidelines are met - Prepares and dispenses hazardous and non-hazardous infusions utilizing sterile techniques, extrapolating data from patient electronic medical records - Compounds study-specific drugs and performs lab-techniques such as culturing live cells, cell counting, and preparing investigational vaccines - In conjunction with the site… Show more - Investigates 400+ human-based clinical research trials according to IRB standards, coordinating with PIs and study teams to ensure protocol guidelines are met - Prepares and dispenses hazardous and non-hazardous infusions utilizing sterile techniques, extrapolating data from patient electronic medical records - Compounds study-specific drugs and performs lab-techniques such as culturing live cells, cell counting, and preparing investigational vaccines - In conjunction with the site director, ensures that completion/accuracy of regulatory documents, training logs, and sponsor-site agreement forms are uploaded and maintained in eTMF - Acknowledges IP shipment, drug returns, destruction, reorder, and assignment to subjects via IVRS - Upholds GCP compliance by tracking the status of critical documentation via eTMF Show less



FAMILY MEDICAL ASSOCIATES, P.A.

• United States
• Medical Practices
• 1 - 100 Employee

• Clinical Research Intern

  • Nov 2018 - Dec 2018

  Levittown, Pennsylvania, United States - Examining source documents and subject visits with the PI, sub-I and study coordinator - Organizing regulatory binders to familiarize with important documents such as 1572, DOA, IRB approvals, IP accountability and critical emails - Monitoring data entry from source documents to CRF in EDC systems (IBM, RAVE…) - Observing site initiation visits (SIVs) for Sanofi and reviewing protocol for the Type 2 Diabetes and low testosterone studies



Temple Health – Temple University Health System

• Hospitals and Health Care
• 700 & Above Employee

• Unit Clerk

  • Jun 2017 - Nov 2018

  Philadelphia, Pennsylvania, United States - Oversees physician orders/ nursing procedures, administrative support for quality patient care - Maintains/updates patient records, coordinates distribution, document retrieval/review - Serves as a liaison/point of contact between physicians, staff and other departments - Organizes and maintains department inventory to ensure efficient patient care - Ensure patients are cared for in a professional and appropriate manner - Shares applicable information and maintain… Show more - Oversees physician orders/ nursing procedures, administrative support for quality patient care - Maintains/updates patient records, coordinates distribution, document retrieval/review - Serves as a liaison/point of contact between physicians, staff and other departments - Organizes and maintains department inventory to ensure efficient patient care - Ensure patients are cared for in a professional and appropriate manner - Shares applicable information and maintain confidentiality of patient and site information - Upholds life care policies, procedures, plans, and abides by local and state regulations Show less



Walmart SuperCenter Pharmacy

• Pharmacy Technician

  • Jun 2014 - Aug 2016

  Norristown, Pennsylvania, United States - Collected information from patients for processing doctor prescribed medications - Inputted prescriptions directions accurately and in a timely manner - Provided and communicated important follow-up information to staff - Handled urgent customer requests efficiently, resolving insurance issues and applying - Prepared and processed medication in a fast paced environment - Maintained equipment and supplies to ensure proper work flow avoiding delays in delivering patient care -… Show more - Collected information from patients for processing doctor prescribed medications - Inputted prescriptions directions accurately and in a timely manner - Provided and communicated important follow-up information to staff - Handled urgent customer requests efficiently, resolving insurance issues and applying - Prepared and processed medication in a fast paced environment - Maintained equipment and supplies to ensure proper work flow avoiding delays in delivering patient care - Reviewed reports/inventory to ensure regulations are maintained and compliance is in order - Multitasks work to meet deadlines and maintain a safe work environment in compliance with federal and state laws and regulations Show less