Paralegal - Medical malpractice defense

• Jan 2023 - Present

Paralegal Certificate Program Graduate

• Dec 2022 - Present

Community Health Education & Outreach RN II

• Apr 2019 - Jun 2021

Lab Project Services Manager/Project Manager

• May 2015 - Jan 2017

• Main point of contact for the customer after study award • Build and own relationship with customer after study award • Project manage study from study award through study closure including development of study plan and risk analysis • Ensure key milestones are met and appropriate resources are available • Monitor quality of study and proactively determine and implement solutions for any issues that arise • Report study progress to internal and external customers • Thorough knowledge and ability to utilize existing Quest Diagnostics Clinical Trials Systems, including but not limited to Encompass, TOPCAT, SMART, Bid sheets and proformas, Result\View, and Qtrack • Comprehensive knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc) • Interface seamless with the study set-up team • Navigate internally, collaborate with internal partners, and develop solutions • Represent Quest Diagnostics at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings • Administer study training to sites, CRA and sponsors and establish regular lines of communication with sites to manage on-going project expectations and issues Show less

Project Manager

• Jan 2014 - May 2015

• Act as primary liaison (i.e. effectively communicate project timelines/milestones, assign workflow, coordinate team meetings) • Support tracking of project budget and scope to ensure timely deliverables and within budget • Establish and maintain client relationships • Schedule project team meetings both internal and with clients • Maintain meeting minutes and circulate for team approval • Support creation of project work plans • Track adherence to project work plans • Track resource needs • Contact and update clients with respect to project progress • Coordinate inter-departmental activities • Provide assistance on new issues and initiatives, opportunities and requirements • Interact and coordinate with outside vendors related to each project (statistician, writers, clinical and data management) as needed • Provide project management assistance to the internal Accenture groups within clinical and regulatory • Work with clinical team in identifying staffing issues and assist with recruiting effort • Provide feedback to clients on best practices and identification of process flaws • Provide regular reports on status and resource needs of ongoing projects • Provide status on all aspects of a project to reporting manager and/or directors • Recommend departmental needs such as staffing, process solutions, efficiency practices Show less

Clinical Editor (Employee and Freelance)

• Oct 2004 - Jun 2014

• Review and clinically edit material for nursing practice books and electronic products • Research expert review and incorporate material as appropriate for electronic products, such as nursing tutorials, procedures, and competencies • Research and select appropriate content for first edition nursing practice books • Coordinator efforts of freelance clinical editors, authors, and expert reviewers for new and updated publications and electronic products • Clinically edit material, research expert review, and incorporate material as appropriate for new and updated nursing practice books and electronic products • Collaborate with design department, editors, copy editors, and clinical director to prepare each product within established budgets and timeframes Show less

Clinical Reserach Nurse Coordinator

• Jan 2002 - Oct 2004

• Coordinate cardiology clinical trials in accordance with FDA regulations and Good Clinical Practice • Review protocol and all study related documents • Prepare and edit documents for Institutional Review Board submissions and renewals • Screen, interview, educate, and recruit eligible research patients • Assure appropriate and safe patient management according to protocol guidelines • Participate in monitoring visits, site initiation visits, and investigator meetings • Maintain all regulatory documents, source documents, and study materials/medications • Coordinate all trial activity in conjunction with investigators, sponsors, monitors, hospital staff, and the research team Show less

Data Management Coordinator

• Dec 2000 - Dec 2001

• Provide data management support for the development in the INVANZ™ antibiotic in response to regulatory agency and clinical requests • Write the Data Management Plan for the entire PhaseIIa/IIb/III INVANZ™ submission and create multiple Table of Contents documents for production tables • Assume protocol lead role for pediatric Phase I study and coordinate case report form design, data collector testing, and query testing in conjunction with other Merck departments • Assist with data management activities for the Colorectal Prophylaxis study (CTS environment) • Serve as INVANZ™/MAXALT® liaison for trainers and ensure proper training is provided to new and veteran employees • Provide ongoing assistance to manager with the recruitment and hiring of high quality staff Show less

Associate in Data Coordination at Merck

• Sep 1999 - Dec 2000

• Review clinical drug trial data from domestic and international subsidiaries to assure completeness and accuracy of case report forms and computer databases in accordance with protocol guidelines • Resolve data inconsistencies with clinical research staff and outside clinical investigators • Perform data entry and domestic and international data review • Maintain evaluability/outcome records through change/add transactions, and the validation/review of production tables, integrated tables, and SAS transport files • Participate in consensus meetings with clinical and statistics to determine appropriate parameters and table of contents components for production (Phase IIb/III) and integrated tables • Create finalized table of contents and assist protocol leads with table production Show less

Registered Nurse

• 1998 - 1999

• Full-time staff nurse on a general medical/cardiology floor • Perform routine patient assessments, administer intravenous and oral medications, interpret cardiac rhythms, perform patient and family teaching, and collaborate with medical team • Complete all necessary documentation • Implement all appropriate therapeutic and technical nursing skills • Full-time staff nurse on a general medical/cardiology floor • Perform routine patient assessments, administer intravenous and oral medications, interpret cardiac rhythms, perform patient and family teaching, and collaborate with medical team • Complete all necessary documentation • Implement all appropriate therapeutic and technical nursing skills