Clinical Research Project Management

Megan Schonert

**** ***** **** *****

Columbia Missouri 65202

402-***-**** • **********@*****.***

Experienced Pharmaceutical Lab Manager;

adept in Quality,FDA Regulations, and Project Management

●Twenty years of diverse industry and clinical environment experience

●Exemplary management and leadership intelligence

●Excellent attention to detail in maintaining quality and compliance

●Proficient in QA, QC, PV, GXPs, and QMS

●Proficient in FDA/USDA/HACCP/ISO/ICH/CMC/MDR

●Creative and innovative problem solver

●Problem solver, goal achiever, and people motivator

CORE COMPETENCIES

Lab Techniques HPLC • GC •UPLC•TGA/DSC •GC/MS• XRD • XRF • FTIR • SEM • ATM •UV/VIS

• Optical Microscope (Leica) •Acoustic Particle Size

Software: • Oracle • OpenLab• Empower •ERP (SAP) • SaaS such as (MS office, Word, Excel, Power Point, Outlook) • Teams• Lab Solutions• LIMS• Cerner (Power Chart) • Citrix (Workspace) • EMR (REDCap)

Regulatory experience: •IRB • IND • IDE • IDS • CDA • CTA • ICF

Clinical Training/Classes: Clinical Trial Investigator • Clinical Research Study Coordinator

Related Experience

University of Missouri, Columbia Mo 2023

Regulatory Affairs Coordinator

●Assisting School of Medicine (SOM) departments in the initiating and opening of externally sponsored clinical research projects and trials

●Proactive in creating/maintaining Regulatory Study binders to house all electronic study related documentation

●Act as the IRB/Regulatory Start-Up specialist and clinical research liaison for MU SOM

●Assisted with Investigational Drug Services (IDS) enrollment processes

●Reviewing requests and granting medical record access to external monitors per institutional processes, rules, and guidelines

●Serve as the primary clinicaltrials.gov administrator for University of Missouri SOM

●Supported the MU SOM clinical research staff by creating and maintaining the educational, onboarding, and offboarding documentation

●Contributed administrative support for clinical research FDA investigational new drug (IND) applications and clinical research FDA investigational device exemptions (IDE).

●Collaborated with CROs/Sponsors/Principal Investigators to determine feasibility of clinical trial studies

●Proactive in the creation and modification of Informed Consent (ICF) documentation

●Assisted in the submittal of Confidential Disclosure Agreements (CDA) and Clinical Trial Agreements (CTA)

●Monitor EMR Account Access and assist Study Monitors with REDCap form completion

●Support upcoming Monitor Visits by assisting in the completion of Remote Records Request/Monitor Visit required documentation

AltaSciences, Columbia MO 2021-2023

Pharmaceutical Laboratory Manager

●Primary resource/SME for all DFA related actions including the construction, design, and commencement of the first on-site Dose Formulation Analysis (DFA) Laboratory for AltaSciences in Columbia Missouri

●Mange the overall operation of the DFA laboratory

●Congruently work with additional AltaScience DFA sites to ensure aligned needs and expectations for DFA

●Effectively communicate elaborate scientific information with Sponsors, Clients, and Stakeholders

●Leveraging strategic relationships with department heads/managers for ongoing, successful collaboration

●Exceptional logical skills with excellence in written and verbal communication skills

●Utilize CAPA/RCA to continually improve processes, identify potential issues and track through completion

●Perform PV of drug formulations by detecting, assessing, understanding adverse effects

●Comply with GXPs and ICH E6 Good Clinical Practices (GCP)

●Perform qualifications and validations on laboratory instruments such as HPLC and UPLC

●Utilize QMS to minimize lab risks, maximize project/sponsor/customer opportunities and satisfaction

●Developed KPIs to instantly assess lab successes and areas of improvement

●Implemented a QbD to ensure continued quality and regulatory standards are constantly being met

●Develop, revise, review, and implement Standard Operating Procedures (SOPs)

●Resolves critical/major issues that are not defined by SOP and that may have impact to regulatory systems

●Assist in the preparation, review, and submission of IND and NDA to the FDA

●Show excellent comprehension and application of FDA regulatory requirements

●Directly manage a team of scientists and chemists working in the DFA lab

●Managed performance of lab personnel and ensuring all personnel adheres to QA and FDA regulations

●Conduct performance reviews and encourage lab personnel to strive for continuous improvement

●Set annual budget/spending and managed expenses within the department

●Collaborate with QA department to ensure DFA lab compliance and address concerns if necessary

●Create DFA standard work, training manuals, controlled/non controlled forms

●Ensure the safety and security of all study related data via practicing data integrity

●Perform R&D and Method Development for DFA testing including validation and qualification testing

●Perform Homogeneity testing, concentration testing, and stability testing

●Cross trained in the Formulations department to encourage collaboration with DFA and TMD departments

●Take part in practice audits to prepare for future regulatory audits (FDA, USDA)

●Serve as lead for 3rd party testing audits and inspections

●Excellent organizational and time management skills to complete all projects on time

●Foster a business environment that encourages continuous learning and progression

●Implement a Laboratory Quality plan and ensure that DFA staff adhere to the quality plan

●Connect with V.P of Operations to communicate needs of lab with staffing, training, etc

●Act as project manager for laboratory and take on independent projects

●Ensure lab is safe and all lab personnel is performing lab tasks in safe manner

Synexis, Lenexa, KS 2019-2021

R&D Chemist

●Assisted Advanced Technologies Group (ATG) in R&D Lab to improve the future and current operation and production of Synexis medical device products

●Assist in 510(K) submissions for Synexis medical devices

●Lead the CMC team with training and guidance

●Assist in the manufacturing operations of Synexis medical devices utilizing GMPs

●Identify places of improvement for catalyst, sail, and sail/product packaging

●Lead, design, characterize, and develop materials of interest for research and development

●Compile and analyze analytical data into reports and present findings to R&D personnel

●Analyze daily catalyst production samples for product qualification

●Understand how Synexis products perform and the vision or goals of Synexis

●Leveraged a broad understanding of material chemistry in order to advance the R&D department

●Collaborated/communicated with additional departments and team members as needed

●Successfully worked on independent projects with little to no supervision and group-led projects

●Lead R&D team to identify problems and draft medical device adjustments

●Managed multiple projects and assignments concurrently

●Maintain ongoing training with new instrumentation

●Serve as SME (subject matter expert) for UV/VIS

●Work with 3rd party companies for outside product testing

●Proficient in lab notebook writing and lab practices/ lab safety

●Strong customer service focus by communicating with customers with limited chemistry knowledge

●Attend weekly Photocatalysis meetings

●Instruments utilized: GC, TGA, GC/MS, XRD, XRF, FTIR, SEM, ATM, UV/VIS Optical Microscope (Leica)

●Rheology instrumentation utilized: Zeta Sizer and viscometer

ADM, Overland Park, KS 2017-2019

Analyst III

●Tested various finished food products using HPLC

●Prepare, analyze, calculate, enter data into LIMs database

●Calibrated scales, ovens, and pipets

●Trained chemists on new instrumentation and SOPs

●Troubleshoot instrument/data issues

●Worked as a team to meet deadlines

●Reviewed existing SOPs for improvements

●Contact hazardous waste removal when necessary

●Attended monthly lab safety meetings

●Keep lab clean and safe of hazards

●Performed testing for:Vitamins (Niacin, folic, Thiamine, Folate, A),Fiber content, Fat content, Moisture content, Protein content

Great Plains Analytical Lab Kansas City, MO 2012-2017

R&D HPLC Chemist

●Chemical Analysis of various finished products following SOPs

●Follow ISO 9001 quality management standards.

●Analysis of 3rd party CPG products on HPLC, GC, and additional scientific instrumentation

●Perform data analysis, interpreted results, entered data into LIMs

●Performed monthly instrument/tools calibration

●Performed weekly lab ordering

●Developed method for sugars (with assistance) and assisted with additional method development

●Train and support new chemists

●Collaborate daily with lab colleagues to delegate tasks

●Lead role in training new supervisor

●Communicated and supported lab staff and lab manager to complete special projects

●Troubleshoot and perform maintenance on instruments

●Troubleshoot current methods for optimization

●Contact hazardous waste removal when needed

●Served as safety scout to laboratory

●Cultivate a safe, clean work environment

●Instrumentation used: HPLC (detectors utilized: UV, RI, and Fluorescence), GC.

Product Testing• vitamins niacin, folic, C, B, D, A content • methionine content •amino acid content

cholesterol content • fat content • mycotoxin content • sugar content • phytic acid content

Education

Bachelors of Science, Biotechnology, University of Nebraska at Omaha 2009

Minor: Chemistry

Manufacturing Associate/Quality Chemist (Internship)

ConAgra Foods, Omaha NE 2005-2009

Worked with food chemists to analyze fibers, sugars, flours, amino acids, toxin contents.

Assisted in the manufacturing warehouse, production warehouse, and continuous improvement areas

Utilized FDA regulated GMPs (21 CFR part 110) during the manufacturing process to ensure effective food safety and quality

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