Clinical Research Assoc II/ Sr Clinical Research Assoc.

Deborah L. Thomas

Clinical Research Associate CRA II

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

Antioch TN 37013

Home 615-***-**** Cell 615-***-**** Email: ad5s8t@r.postjobfree.com

Education

Brigham Young University

Bachelors of Science

Medical Botany

Middle Tennessee State University

Masters of Science

Biology (Drug Research and Development)

Summary

Over 4 years of experience working in Bio-medical drug development research with two pier reviewed publications on Anti-Cancer drug discoveries

Over 25 years of combined experience as Instructor/Project Manager/Director

Over 3.3 years of combined experience working for Syneos & ICON Clinical Research

Clinical Research Therapeutic Areas include:

Vaccine

Infectious Disease

Pneumococcal Conjugate Vaccine (Pediatric) Pfizer

Pneumococcal Conjugate Vaccine (Adult) Pfizer

SARS-COV-2 mRNA Vaccine (Adult) Pfizer

Pneumococcal Conjugate Vaccine (Pediatric – Adult, range 4 months to 18 years) Pfizer

Device Trial

Phycological

VNS Device Therapy for Treatment Resistant Depression (adult) Liva Nova

Cosmetic

Dermatological

Belotero Intense Lidocaine for Lip augmentation (adult) Merz North America, Inc.

Oncology

Colorectal Cancer Stool and Blood screen for Colorectal Cancer (adult) Exact Science

Oncology

Kaladiscope/ METalmark Study on NSCLC Phase 1 & 2 Treatment with Amivantamab &

Catmatinip (adult) (Janssen)

Amplitude Phase 3 Study on Prostate Cancer - Niraparib in Combo/Abiraterone Acetate &

Prednisone

Professional Skills: Self–management, Technical Writing, Communication, Analytic Thinking, Creativity, Scientific and work ethics, Time management, Adaptability, Experimental Design, Team Focus, Presentation Expertise, Acuity, Negotiating, Client Relations, Organization, Insight, Integrity, Professionalism, Public Speaking.

Experience in Electronic Data Capture Systems: Citrix Database Management System, INFORM, Florence, Complion, Pfizer-TMF (Seibel), Fire Crest, IBM, BioClinica/Clario, Medidata, RAVE & CTMS, Realtime, IXRS/Almac,Sharp, Signant Health IRT (Bracket), YPrime, XSP-Labcorp, Drug Dev(Spark or I Quiva), Guardant…etc…

Languages: English (verbal and written: technical writing)

Publications:

o[PUBLICATION] Almosnid, N. M., Zhou, X., Jiang, L., Ridings, A., Knott, D., Wang, S., Wei, F., Yuan, J., Altman, E., Gao, Y., Miao, J. 2018. Evaluation of extracts prepared from 16 plants used in Yao ethnomedicine as potential anticancer agents. Journal of Ethnopharmacology. 211:224-234.

o[PUBLICATION] : Alsaif, G., Almosnid, N., Hawkins, I., Taylor, Z., Knott, D. L. T., Handy, S., Altman, E., Gao, Y. 2017. Evaluation of fourteen aurone derivatives as potential anti-cancer agents. Current Pharmaceutical Biotechnology. 18:384-390.

Professional Experience

Syneos Clinical Research

Clinical Research Associate CRA II

April 2023 to Jan 2024 Job Description

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.

Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patients' safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes:

o Conducts Source Document Review of appropriate site source documents and medical records

o Verifies required clinical data entered in the case report form (CRF) is accurate and complete

o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

o Verifies site compliance with electronic data capture requirements.

May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

The CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:

o Site support throughout the study lifecycle from site identification through close-out

o Knowledge of local requirements for real world late phase study designs

o Chart abstraction activities and data collection

o Collaboration with Sponsor affiliates, medical science liaisons and local country staff

o The SMA II may be requested to train junior staff

o Identify and communicate out of scope activities to Lead CRA/Project Manager

o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

ICON Clinical Research

Clinical Research Associate CRA I

December 2021 to April 2023 Job Description

Impart ongoing support to site staff, CTM & PM to ensure the efficacy and efficiency of the clinical trial, and in processing and resolving queries, action items and requests in a timely manner.

Conduct and complete Pre site evaluations and visits, onsite and remote site monitoring, close out visits and management activities, providing needed support according to applicable SOPs and Study Monitoring Plan.

Meet with PI’s and SC to discuss subject safety, adherence to protocol and data integrity as well as discuss and retrain if necessary, as a result of present findings from monitoring visits and offer answers, aid and solutions to pending concerns.

Serve as a contact contact for participating sites and investigators.

Encourage sites in developing and implementing their recruitment plans and continued compliance to protocols, retention of subjects and registration in current registries as well as longitudinal registries.

Compose & coordinate comprehensive trip reports consistently as per format for source review including Clinical Site Status, CRF review and Queries, PD’s, SAE/UADE Device Safety Deficiency reviews, and other Safety Reviews, ICF Review, Site Personnel reviews, Action Items, missing documents, EDC omissions and errors, CDA findings, and sponsor specific assigned tasks.

Encourage and train sites on effectively managing timely data entry into EDC study systems.

SDV and SDR with internal reports, EDC and other tracking tools.

SAE, & AE tracking and resolution.

Training and retraining of site staff as needed for adherence to sponsor protocols.

Arrange for the distribution of study supplies

Conduct onsite meetings with PI and SC and other applicable staff to present findings and suggest solutions or retrain as needed.

Create reports and trackers to monitor study.

Book travel and submit expense reports.

Attend and contribute to team meetings.

Execute other projects as assigned.

Syneos Clinical Research Associate

April 2023 to Jan 2024 (Study) A Phase 3 Randomized Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene- Mutated Metastatic Castration-Sensitive Prostate Cancer(mCSPC).

Responsibilities:

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Belarus, Brazil, Canada, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hungary, Israel, Italy, Korea, Malaysia, the Netherlands, New Zealand, Poland, Russia, Sweden, Thailand, Turkey, Taiwan, Ukraine, & South Africa. (100+ sites).

Study stages handled: Enrollment close, Monitoring, Data-Lock & Study Close out.

Other Significant Responsibilities: Tracks training and education of site and study staff in the conduct and management of sponsored studies including assurance to regulatory and ICH/GCP compliance and protocol guidelines while demonstrating an understanding and applied knowledge of the therapeutic area as it relates to project related issues and retrains is needed. Provides site management and monitoring support for sponsored clinical studies, conducts site onsite monitoring visits, co-monitoring visits and site closure visits and prepares site visit reports and follow-up letters to assist site staff in resolving deficiencies. Conducts reviews of the ISF and collects and processes regulatory documentation and assists in the protocol, informed consent and CRF design and review. Initiates resolution of issues and actions, queries, enrollment issues, protocol deviations, SAE, AE resolution and other issues. Keeps currents with site correspondence and site needs, training reconciliation, sponsor training, report generation and analysis; supply management, defective device tracking, Covid 19 tracking and closures, researching and solving training issues, tracking device returns, tracking IP and other special projects as needs arise. Appropriately resolves issues related to monitoring with team support as needed.

Syneos Clinical Research Associate

April 2023 to Jan 2024 (Study) A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-Small Cell Lung Cancer (METalmark).

Responsibilities:

Countries: United States, Turkey, Canada, United Kingdom, France, Germany, Italy, Brazil, South Korea, Japan & China (<35 sites).

Study stages handled: Enrollment, Site Initiation Visit, Monitoring, Data-Locks and Site closure.

Other Significant Responsibilities: Preformed SIV and educated and trained all site and study staff in the conduct and management of sponsored studies including assurance to regulatory and ICH/GCP compliance and protocol guidelines while demonstrating an understanding and applied knowledge of the therapeutic area as it relates to project related issues. Provides site management and monitoring support for sponsored clinical studies, conducts site onsite monitoring visits, site closure visits and prepares site visit reports and follow-up letters to assist site staff in resolving deficiencies. Tracks and qualifies screening and enrollment strategies, including financial assistance opportunities. Reviews the ISF and collects and processes regulatory documentation and assists in the protocol, informed consent and CRF design and review. Initiates resolution of issues and actions, queries, enrollment issues, protocol deviations, SAE, AE resolution and other issues. Keeps currents with site correspondence and site needs, training reconciliation, sponsor training, report generation and analysis; supply management, defective device tracking, Covid 19 tracking and closures, researching and solving training issues, tracking device returns, tracking IP and other special projects as needs arise. Appropriately resolves issues related to monitoring with team support as needed.

ICON Clinical Research Associate

November 2022 to April 2023 (Study) Clinical Validation of an optimized multi-target stool DNA (mt-sDNA 2.0) test, for Colorectal Cancer Screening Blue-C. AND, Blood Collection Sub-study of Exact Sciences Protocol: “Clinical Validation of an optimized multi-target stool DNA (mt-sDNA 2.0) test, for colorectal cancer screening Blue-C.

Responsibilities:

Countries: United States (100+ sites).

Study stages handled: Enrollment, Monitoring, Data-Lock & Study Close out.

Other Significant Responsibilities: Educates and trains site and study staff in the conduct and management of sponsored studies including assurance to regulatory and ICH/GCP compliance and protocol guidelines while demonstrating an understanding and applied knowledge of the therapeutic area as it relates to project related issues. Provides site management and monitoring support for sponsored clinical studies, conducts site onsite monitoring visits, co-monitoring visits and site closure visits and prepares site visit reports and follow-up letters to assist site staff in resolving deficiencies. Reviews the ISF and collects and processes regulatory documentation and assists in the protocol, informed consent and CRF design and review. Initiates resolution of issues and actions, queries, enrollment issues, protocol deviations, SAE, AE resolution and other issues. Keeps currents with site correspondence and site needs., sponsor and Icon training, report generation and analysis; supply management, defective device tracking, Covid 19 tracking and closures, researching and solving training issues, tracking device returns, tracking IP and other special projects as needs arise. Appropriately resolves issues related to monitoring with guidance from CTM & PM as needed.

August 2022 to April 2023 (Study) A Prospective, multicenter, randomized Comparator-controlled, evaluator-blinded study to evaluate the safety and effectiveness of Belotero Intense Lidocaine for lip augmentation.

Responsibilities:

Countries: United States (100+).

Study stages handled: Pre-SV and site selection

Educates and evaluates potential sites and study staff as to their ability in the conduct and management of sponsored study including assurance to regulatory and ICH/GCP compliance and protocol guidelines while demonstrating an understanding and applied knowledge of the therapeutic area as it relates to project related issues.

Educates and procures documents related to confidentiality and setting up sites for potential participation in the trial.

April 2022 to December 2022 (Study) Recover: A Prospective, Multi-Center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No-Stimulation Control in Subjects with Treatment-Resistant Depression

Responsibilities:

Countries: United States (79 sites).

Study stages handled: Enrollment, Monitoring, Data-Lock & Study Close

Other Significant Responsibilities: Educates and trains site and study staff in the conduct and management of sponsored studies including assurance to regulatory and ICH/GCP compliance and protocol guidelines while demonstrating an understanding and applied knowledge of the therapeutic area as it relates to project related issues. Provides site management and monitoring support for sponsored clinical studies, conducts site onsite monitoring visits, co-monitoring visits and site closure visits and prepares site visit reports and follow-up letters to assist site staff in resolving deficiencies. Reviews the ISF and collects and processes regulatory documentation and assists in the protocol, informed consent and CRF design and review. Initiates resolution of issues and actions, queries, enrollment issues and other issues. Keeps currents with site correspondence and site needs., sponsor and Icon training, report generation and analysis; supply management, defective device tracking, Covid 19 tracking and closures, researching and solving training issues, tracking device returns, and other special projects as needs arise. Appropriately resolves issues related to monitoring with guidance from CTM & PM as needed.

ICON Clinical Research

Job Description

In House Clinical Research Associate (IHCRA)/

June 2021to March 2022

• Impart ongoing CTM, PM, and CRA support to ensure the efficacy and efficiency of the clinical trial, and process and resolve queries and requests

•Conduct and complete remote site management activities, providing needed support according to applicable SOPs and Study Monitoring Plan.

•Serve as primary in-house contact for participating sites and investigators

•Monitor and maintain study files in the eTMF

•Learn principles and assist with investigator recruitment and track site enrollment updates

•Compose & coordinate emails consistently for specific requests, missing documents or visits, data entry omissions and errors, data queries, CDA findings, action items and sponsor specific assigned tasks.

• Reconcile internal documents in eTMF with sites

• Effectively manage timely data entry in study systems

• Organize, compile & distribute study supplies

• Present solutions and contribute in study meetings

• Create reports and trackers to monitor study

• Correspond with sites updating site trainings

• Track queries, address issues & actions with site follow-up

• Stand as emergency contact for study sites when CRAs are inaccessible

• Execute other projects as assigned

ICON Clinical Research

IHCRA In-House Clinical Research

Associate June 2021 to March 2022 (Study)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A XX-XXXXXX PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS - AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS. IN HELATHY CHILDREN 15 MONTHS TO 17 YEARS OF AGE

Responsibilities:

Countries: United States (91 sites).

Study stages handled: Enrollment, Monitoring, Data-Lock & Study Close

Other Significant Responsibilities: Icotrial and TMF follow up letter submissions, 1572/CV & financial disclosure tracking, Trial master file submissions and document tracking and place holder reconciliation tracking, resolution of issues and actions, updating enrollment, obtaining GRAFs and ICD reconciliation, updating software accesses for sites and maintaining critical documents in central files, site correspondence, transferring documents between EDC systems, keeping current with sponsor and Icon training, report generation and analysis; supply management, serum sample tracking, Covid 19 tracking and closures, researching and solving training issues, tracking device returns, emailing CRAs site tasks and special projects for the study as assigned and mentoring other onboarding IHCRAs colleagues while setting a standard of excellence.

ICON Clinical Research

Job Description

Clinical Trial Assistant

Oct 2020 to May 2021

• Impart ongoing CTM, PM, and CRA support to ensure the efficacy and efficiency of the clinical trial.

• Monitor and maintain study files in the eTMF

• Compose & coordinate mass mailings

• Reconcile internal documents in eTMF with sites

• Effectively manage timely data entry in study systems

• Organize, compile & distribute study supplies

• Contribute in study meetings and take meeting minutes

• Observe and monitor study through reports and trackers

• Correspond with sites collecting documents, aiding in patient enrollment, and updating site trainings

• Track queries, address issues & actions with site follow-up

• Stand as emergency contact for study sites when CRAs are inaccessible

• Execute other projects as assigned.

CTA

Oct 2020 to May 2021 (Study)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A XX-XXXXXX PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS AND ADULTS

Responsibilities:

Countries: United States and Puerto Rico (188 sites).

Study stages handled: Study start up, Enrollment, Monitoring, Study Closing out.

Other Significant Responsibilities: Trial master file submissions and reconciliation, 1572/CV & financial disclosure tracking, tracking site trainings, resolution of Issues and actions, updating enrollment, obtaining GRAFs and ICD reconciliation, clinical data entry and maintaining critical documents in central files, site correspondence, transferring documents between EC systems, report generation and analysis; updating central files, supply management, serum sample tracking, site Covid 19 survey tracking, meeting organization with minutes, researching and solving internal document issues (ODQA), study plans/logs tracking and emailing CRA site tasks and special projects as assigned.

CTA

Dec 2020 to Feb 2021 (Study)

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 XXX VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Responsibilities:

Countries: Global (No of sites):

Study stages handled: Enrollment, Monitoring, Study Closing out

Other significant responsibilities: Reconciling CRA trainings and updating trackers, filing trainings in various software, Email blasts to CRAs, working with CTMS/ COM’s in reconciliation of trainings, maintaining critical documents in central files.

CTA

Oct 2020 to May 2021 (Study)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A XX-XXXXXX PNEUMOCOCCAL CONJUGATE VACCINE (XXXXX) WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 65 YEARS OF AGE

Responsibilities:

Countries: United States (109 sites)

Study stages handled: Enrollment, Monitoring, Study Closeout

Other significant responsibilities: Trial master file submissions and reconciliation, clinical data entry and tracking, granting and revoking accesses to electronic data systems, posting and maintaining critical documents in central files, site correspondence for document retrieval and mass email correspondence, transferring documents between systems, report generation and analysis; global/internal calls, study file management, meeting organization with minutes, researching and solving internal document issues (ODQA), study plans/logs, tracking Firecrest training, and special projects as assigned.

TN Center for Botanical Medical

Research

Researcher/Project Manager

Aug 2013 to Dec 2017

Job Description

Investigative anti-cancer research project on extracts derived from Traditional Chinese Medicine (TCM) Microplate platform testing in pursuit of new drug discovery of anti-Cancer agents and development of biologics in partnership with Chinese Government.

Bench research in extraction development, protocol design, experimental design and development.

Quality control, data compilation, data analysis and determinations.

Consulting with department teams and principle investigator about issues related to research expectations, goals, protocols, planning and problem-solving strategies.

Training of visiting Chinese colleagues and others.

Named author on (2) International pier reviewed publications.

Middle Tennessee State University (MTSU)

Adjunct Faculty & Graduate Teaching Assistant

Aug 2013 to Dec 2015

Job Description

Instructor-microbiology pre-med course and nursing majors, teaching a full complement of students

Instructor-biology courses for science majors, teaching a full complement of students

Prepared course material PowerPoints, lecture, support materials and experimental design for Labs

Officer on the faculty council for student disciplinary action

Supported students with mentoring and group tutoring

Preformed administrative duties, provided administrative support with prepared reports, attended meetings addressing student disciplinary actions, weekly planning meetings, issued grades and participated in facility council for student pass/fail ratios.

Nashville CPA Firm (Sold)

Job Description

Co-Owner & Managing Director

Jan 1994 to Nov 2018

TN O.S.H.A

Compliance Officer

Jan 1993 to Jan 1994

The Advent Group

Botanist/Aquatic Tox Lab

Project Manager EPA Testing

Oct 1991 to Dec 1992

Oversaw all firm operations, coordination of teams, resources identification and procurement, schedules, time tables, project management, goal setting, innovation, planning, scope and strategies, communications and implementation while interfacing with clients and collaborating with other supporting peer professionals and leading associates to assist clients needs and realize company performance and growth goals.

Organized committees, evaluated risks, defined success measurements, tracked project reports and project managers using several software applications and weekly meetings.

Grew business successfully for years, servicing thousands of clients, helping them achieve success in their prospective business; then sold the family business in 2018 to pursue clinical trial research.

Job Description

Conducted onsite inspections of facilities for violations of health and safety codes.

Generated reports and wrote narratives of site investigations and assigned fines and attended arbitrations and well as many other duties.

Job Description

Responsible for all EPA Toxicology lab certification testing.

Supervised aquatic team assistants in working with waste water, performing portions of tests, waste water disposal, lab maintenance, and many other duties. Pioneered Micro-Tox testing protocols, generated reports, made assessments and recommendations and presentations.

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