EMILY WALKER

SUMMARY

A highly motivated and personable Clinical Research Professional with substantial experience within the clinical pathology and pharmaceutical research environments. Key experiences are within Renal Disease, Analgesia, and Psychiatry.

EXPERIENCE

Date: From January 2023 to Present

Company Name: Randstad Life Sciences/Reistone BioPharma Job title: eTMF QC Reviewer

• Perform TMF QC Review at the site, country and study level for project

• Provide alerts relative to missing, inaccurate or incomplete elements.

• Provide external and internal communication support via face-to-face interactions as well as email, fax, phone, scanning technologies and/or web-based communications.

• Supports the clinical teams and clinical monitors in accordance with GCPs, global SOPs, local country regulations and study protocols to ensure timely and compliant conduct of clinical trials. Date: From October 2022 to December 2022

Company Name: Databean, Inc.

Job title: eTMF Specialist

• Worked on various clinical trial document management processes, including preparing and maintaining detailed SOPs/workflows/plans

• Assisted with the collection of essential documents for clinical trial start-up including site budgets and contracts

• Assisted in eTMF audits (internal and external)

• Participated in study/project/quality team meetings and prepares minutes

• Managed action items from team meetings

• Assisted with the implementation of process changes and upgrades

• Assisted other projects as needed

Date: From December 2021 to July 2022

Company Name: Premier Research

Job title: Project Specialist

● Partnered with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety).

● Collaborated with the team in the collection of information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases.

● Built working relationships with the project team to resolve issues at the study level.

● Collaborated with the cross-functional team to identify risks associated with milestones and deliverables and updated risks on study risk log.

● Applied standard operations procedures (SOPs) and ICH/GCP best practices in all responsibilities assigned.

● Partnered with the PM, CL, and functional leads to initiate team communication and documentation internally and externally. Maintained internal and external project team contact lists.

● Ensured effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log. Supported the CL in the creation and distribution of study newsletters as required.

● Applied study knowledge to maintain, update, and disseminate study timelines in accordance with the study proposal, as well as feedback from functional groups and the sponsor.

● Partnered with the PM in developing, maintaining, and updating financial tools to track project budgets. Helped to identify and track out of scope services and assists in preparing Change Orders.

● Supported the management of timely approval and tracking of pass-through invoices in accordance with the executed Clinical Trial Agreements. Tracked supplies, invoices, and budgets relating to vendor management, as appropriate.

● Collaborated with the team to ensure assigned projects are audit ready; i.e., project tasks were completed in accordance with project plans (customizes project templates when applicable) and SOPs and are filed to TMF, as appropriate. Initiated TMF development (TMF filing plans, tracking/qc tools, and TMF access); ensured functional group compliance and that the TMF is accurate, complete, and audit ready at all times. Helped to identify and track applicable SOP updates and SOP Deviations at the study level.

● Created and maintained the required project systems, SOP indices, and study team lists, as applicable.

● Managed study team/contact lists, system access requests, and e-mail distribution lists as required.

● Collaborated with the functional leads in the development of team training or meeting presentations and maintained the study training matrix. Ensured completion and proper documentation of study specific training requirements as directed by the PM.

● Assigned additional project / ad hoc activities to manage independently. Develops and provides training and support to other team members, as appropriate. Leads department improvement activities.

● Acquired additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures. Participated in corporate initiatives and actions that ensure the continued success of the company. Date: From April 2021 to December 2021

Company Name: George Clinical

Job title: Clinical Trial Specialist

● Prepared and submitted site IRB Submission packages and managed IRB submissions, including review and confirming accuracy of approved IRB documents.

● Maintained database of site information from feasibility questionnaires (FQ Database), including site profiles for George Clinical investigator database

● Managed distribution, collection, and tracking of signed CDAs

● Provided ongoing reports and updates to the project team according to required timelines and project deliverables

● Assisted in coordination of feasibility process and served as primary point of contact during feasibility process for proposed and assigned trials, including identifying site list for blinded and un-blinded feasibilities as requested by Clinical Operations management

● Collected essential documents from sites on a designated schedule.

● Established and maintained the Trial Master File (TMF) via hard copy and/or shadow or eTMF as assigned by project.

● Provided data entry support for the investigator payment database by project, with input from appropriate project management.

● Assembled and prepared shipments for site study materials.

● Interfaced with project vendors as needed.

● Addressed and triaged questions from study sites and maintained regular contact with sites to obtain feedback on study procedures and identification of site-specific problems. Date: From July 2019 to April 2021

Company Name: George Clinical

Job title: Associate Clinical Trial Specialist

● Assisted in Trial Master File (TMF) set-up and maintenance, including uploading and maintaining TMF files and folders in George Clinical’s file-sharing system both hard copy and electronic.

● Provided data entry support for the ClinPlus investigator payment database.

● Provided assistance in maintaining project start-up and maintenance trackers as well as maintaining metrics for associate-level deliverables as instructed by clinical operations management

● Corresponded with multiple departments as needed to ensure open and ongoing communications regarding project-specific activities, especially as related to project timelines

● Interfaced externally with study sponsors and study sites as assigned Date: From August 2013 to March 2019

Company Name: Trumbull Laboratories

Job title: Cytoprep Technician

● Trained staff on specimen accessioning and laboratory protocols.

● Routinely assisted with fine needle aspiration biopsies via ultrasound, in conjunction with Trumbull's director of cytopathology.

● Successfully coordinated the workflow of the cytology laboratory, including maintaining inventory, troubleshooting laboratory equipment, and facilitating consistently positive audit outcomes.

THERAPEUTIC EXPERIENCE

Therapeutic Area & Phase

● Renal, US and Global

o Registry Studies

● Analgesia, US

● Rare Disease, US and Global

● Psychiatry, US

EDUCATION

Year: 2019

Health Information Management, Western Governors University, Salt Lake City Year: 2012

Phlebotomy Certification, Tennessee College of Applied Technology, Nashville Year: 2007

Psychology/Mass Communication, Middle Tennessee State University, Murfreesboro LANGUAGES SPOKEN

Native language: English

Other languages: German (basic)

PROFESSIONAL AFFILIATIONS

● Member, ASCP (PBT)

SIGNATURES

Employee Signature:

Date:

Printed Name: Emily J. Walker

31JAN2023

BIOGRAPHY

Clinical Trials Specialist

Emily Walker

Based in Memphis Tennessee, United States

From October 2022 to December 2022, Emily worked with Databean Inc., as an eTMF Specialist. Emily was previously employed at Premier Research as a Project Specialist in the Project Planning and Management department from December 2021 to July 2022. From July 2019 to December 2021, Emily was employed as a Clinical Trial Specialist at George Clinical in Memphis, building a foundational knowledge of the CRO’s role in managing clinical trials. From 2013 to 2019, Emily worked as a Cytoprep Technician at the pathology group Trumbull Laboratories, in the Cytology Department. To date, Emily’s most notable therapeutic experience is at George Clinical where she was part of a small team tasked with managing a global renal disease registry study. This renal disease platform activated sites in North America, Europe, Asia, South America, and Australia. Between 2019 and 2021, Emily studied at Western Governors University, pursuing a bachelor’s degree in Health Information Management. In 2013, Emily received her certification as a Phlebotomy Technician in Nashville at Tennessee College of Applied Technology. Emily began her college career in 2002 at Middle Tennessee State University, double majoring in Psychology and Electronic Media Communication.

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