Lavezza Z. Johnson Email & Phone Number

Remote

Responsible for the overall coordination and management of clinical trials from start up through to final deliverables. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the customer's time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing with the support of Project Management Directors and/or Associate Directors while working in collaboration with other functional area leads.

Atlanta, Georgia, United States

*Creates, Implements, and Executes project scope of work adhering to county, state, and industry specific regulations.*Hires, Contracts, and manages subcontractors (plumbers, electricians, hvac, roof, engineers, architects, third party inspectors)*Bid & proposal reviews. *Draft invitation to bids. *Monitors & Submits Change Orders, along with scheduling county and third party inspections. *Procurement of materials & equipment for projects.*Completes project installations (framing,drywall, cabinetry, vanity,sinks,bathroom & kitchen remodeling)*Direct activities meeting client specification(s), ensuring quality deliverables on time and within budget.*Conducts client/stakeholders/contractor meetings and communications, report progress, issue resolutions, and budget oversight.*Maintains financial oversight of contracts, contractors effort, customer budget, payments, and vendor payments. *Review and analyze operational, quality, and performance-timeline metrics to assess the success of project oversight activities.*Create & Implement operating procedures and process improvement strategies.

Greater Atlanta Area

-Assist with the proper management and coordination of clinical trails. -Working alongside Principal Investigators to initiate and realize their scientific protocols.-Project management, negotiations, drafting of study documents. -Study monitoring.-Liaison between sponsors and Principal Investigators to achieve specified goals.-Creation and submission of protocols, grants, consents, etc. to governing bodies (i.e. Sponsors, IRB)-Creation of reports displaying progress of projects.-Program Evaluations.To schedule a consultation email us at zandersconsultingllc@gmail.com

Remote

*Responsible for the management and delegation of, responsibility for, ongoing management and oversight of clinical trial study projects. *Direct activities to meet our client’s specification, ensuring quality deliverables on time and within budget. *I also serve in the day-to-day management of specific moderate and high complexity projects.*Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.Participates in the handover process between Business Development (BD) and the Project Initiation Services team (PIS).*Primary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to.*Works closely and in coordination with clinical laboratory management and directors in support of clinical trials.*Review of reports and documents, including enrollment logs, pending test reports, reporting from other laboratories, issue logs, shipping manifests, and other documents that assist with study oversight.*Review and analyze operational, quality, and performance-related metrics to assess the success of study oversight activities.*Liaise with managers/supervisors in other departments to stay informed of operational changes.*Collaborate with project managers in partner laboratories to provide a global overview of study management.*Coordinate requests for shipment of stored samples as directed in the SOW.*Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices.*Represents LabConnect at the client and/or investigator meetings.*Performs other related duties and tasks as necessary or as assigned.

• Conduct patient screening, baseline, treatment, follow-up and study-related visits, and manage the start-up through close-out aspects of clinical trials; ensuring efficient and high-quality clinical trial operations.* Ensure proper ALCOA documentation to ensure validity and patient safety. * Process and submit CDAs, IRB/WIRB submissions, and regulatory documents (1572, FDFs, etc.) for the GI research department. • Execute the understanding of safety reporting guidelines and monitoring for reporting Adverse Events (AEs) and Serious Adverse Events. • Lead clinical research requirements including GCP,ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research.• Communicate hospital research guidelines to sponsors, PIs, patients, monitors, IRBs, vendors and other key stakeholders throughout studies. • Monitor and execute clinical investigations involving humans in accordance with Guidelines for Good Clinical Practice, ICH Clinical Safety Data Management, Definitions and Standards for Expedited Reporting, the United States Code of Federal Regulations, and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. • Mentor and support other CRCs, including conducting quality control checks and internal monitoring of work and providing coaching / feedback to promote professional development.• Conduct quarterly supervisory and staff training's on management strategies and research changes. • Streamline regulatory, pre-screening, and scheduling processes for four PI's with 21 clinical trials and four registries; While creating SOPs reflecting implemented infrastructure.

Greater Atlanta Area

-Manages Regulatory & Compliance Affairs for the Division's National Institute of Health and other industry sponsored clinical trials and non-clinical trial protocols.-Oversees financial management of grants.-Study operationalization, activation, and termination.-Serves on Research Board Committee.-Leads collaboration with sponsors, internal research administrators, coordinators, and investigators among other cross-functional internal and external units. -Assists in directing the strategic planning, development, and implementation of programs/projects.

-Coordinates, reconciles, and oversees financial management of over 60 National Institute of Health and other industry sponsored clinical trials and non-clinical trial protocols.-Ensures research compliance.-Trains staff and clients on operations and/or databases.-Specialized in Neurology, Digestive Diseases, Hematology/Oncology, and Cardiology protocols/accounts. -Creates and revises SOP's and quick reference guidelines.-Reviews study protocols for financial and resource feasibility.-Reviews Prospective Reimbursement Analysis, budgets, and contracts for discrepancies.-Reviews charges per the contract and PRA for proper routing.-Monitors data entry for subject activity in centralized databases.-Develops budgets and identifies budget discrepancies.-Process' and verifies Accounts Payable & Receivables.-Assists with resolving billing issues with P-Card vendors, Accounts Payable, Accounts Receivable, Emory Clinics, & Emory Hospital.-Reviews contracts and indemnification agreements.-Initiate contract amendments.-Adheres to the Cost Accounting Standards and justifies exceptions for approvals.-Analyzes and presents financial status and statistical data.-Negotiates and prepares best and final offers.-Assist with preparing University's fiscal year budgets.-Prepares technical progress reports.-Assures compliance with expenditures for small disadvantaged business subcontracts.-Conducts & host outreach meeting with clients.-Assist Principal Investigators with operationalizing their protocols.

-Independently managed significant and key aspects of a large clinical trial and all aspects of five small trials.-Provided training and guidance to less experienced staff. -Overseen data management for research projects.-Interfaced with research participants and resolves issues related to study protocols. -Authorized purchases for supplies and equipment maintenance. -Determined effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. -Audited operations and proper signage for research laboratory to ensure compliance with applicable Federal and University regulations; -Provided leadership in identifying and implementing corrective actions/processes.- Monitored and created multiple IRB and Sponsor Regulatory Affair submissions and responds to requests and questions.-Worked with numerous sites including Grady Hospital & Emory Hospital.-Interfaced with study sponsors, monitors and reported SAEs-Resolved study queries. -Provided leadership in determining, recommending, and implementing improvements to policies/processes. -Assisted with the development of grant proposals and protocols.-Performed phlebotomy, specimens collection and specimen processing.-Completed training for IV therapy.-Submitted study related reimbursements, billing for research visits, and monitored study budgets.-Assisted with study start-ups, review of PRAs, and invoicing statements.

•Prepares food samples for microbiological testing and maintains documentation of the process to facilitate analysis procedures•Read plates and tubes to determine the number of organisms in the sample. • Record findings on worksheet for verification. •Write identification onto plates so that client and sample number can be tracked. •Pipette sample solution into tubes or plates according to the analysis process being performed. Pour the agar into plates or tubes to begin the growth process. •Prepare sample for analysis by recording, weighing, and blending. •Collect plates and place them in the incubator for the specified amount of time and temperature. •Prepare media and broth for use in pathogen testing as required. •Sterilize materials needed for analysis. Autoclave plates before discarding. •Ensure that media and materials are prepared for the next testing sequence. •Maintain knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities. •Set up equipment and materials needed for analysis. •Support corporate quality and continuous improvement process.

Public Health

Bachelors Of Science, Biology, Premed

Activities and Societies: Tri-Beta Honor Society;Iota Phi Lambda Sorority, Inc.; Sigma Gamma Rho Sorority, Inc.; Field & Track Program.

Biology-Visiting Student

Education record