Clinical Administrator

EVETTA HARRIS

**+ years of experience working for Biopharma, CROs, and GMP facilities across global trials (Phases 1-4). Diverse administrative background in customer service. Adept at managing clinical trials end-to end with understanding of global programs. In depth experience in document development, site coordination, auditing, Quality (QA), and cross-functional team engagement at small and large Pharma companies. Committed to delivering results against mission goals. Excellent interpersonal and communication skills. Initiative-taking, purpose-driven, enthusiastic and mature asset to any team.

Employment History

Clinical Administrator

Maximus June 2025-Present

●Work directly with HCBS (Home and Community Based Services) for the state of Kansas providing different services that allow those who need care to receive services in their homes or communities.

●Ensure elderly and developmentally disabled individuals receive appropriate care services in compliance with state and federal regulations.

●Manage clinical assessments, review eligibility determinations, and provide guidance to assessors and care teams.

●Maintain a strong knowledge of Medicaid, long-term care programs, and regulatory compliance, along with experience in clinical oversight and process improvement.

Call Center Supervisor

FEMA (Maximus), Remote Contract Apr. 2024-Mar. 2025

●Managed call center agents contracted with MAXIMUS on the FEMA project.

●Facilitated daily pre-shift meetings for team guidance and instruction.

●Evaluated employees' job performance, recommending appropriate personnel action, including disciplinary action, performance improvement plans, and termination through partnering with Human Resources if necessary.

●Ensured accuracy of timesheets and schedule adherence.

●Monitored agent calls and mentored regularly. Performed operational tasks assuring project and program service level requirements and goals were met, including analyzing agents’ quality performance and trending call types.

●Worked closely with Sr. management to perform other duties as assigned, leading by example.

Helpline Tier 2

FEMA (Maximus), Remote Contract

●Responded to complex incoming calls transferred from Tier1 agents regarding Federal Emergency Management Agency applications.

●Assisted Tier 1 agents with call assessment and training as needed on how to best assist survivors during phone inquiries.

●Utilized advanced technology and critical thinking skills to de-escalate various situations and work tasks.

●Responded to all inquiries consistent with confidentiality and privacy policies and refers callers to alternate sources when appropriate.

●Collaborated closely with the Supervisors to resolve difficult and complex consumer interactions.

Stantonsburg, NC 27883

Phone: (984) 206-027

Email: ********@*****.***

Education

High School Diploma

Northern Nash Sr. High

Expertise

●Global Programs PH 1-4

●Compliance Verification

●Site Management

●FDA GCP ICH Guidelines

●Internal and External Audits

●Institutional Review Board (IRB) Submissions

●Quality Management System (QMS)

●VEEVA Vault

●Trial Master File (TMF)

Skills

Databases:

●VEEVA Vault (5+ years)

●TrackWise (3 years)

●PMED (5 years)

●eClinical

●MS Project

●Oracle 6.0

●Electronic Patient Diaries

●Endpoint IWRS

●Planisware Orchestra

●Emmes

Programs:

●MS Office (Word, Excel, PPT)

●Smartsheets

●Sharepoint

●MS Teams

Data Processor 1

FEMA (Maximus), Remote Contract Jul. 2024-Feb. 2024

●Responded to complex incoming calls transferred from Tier1 agents regarding Federal Emergency Management Agency applications.

●Facilitated the registration process for disaster survivors ensuring accurate and efficient data entry for Federal Emergency Management Agency applications.

●Met Quality Assurance (QA) and other key performance metrics.

●Tracked and documented all inquiries using applicable systems.

●Maintained accurate knowledge of the Contact Center performance requirements as well as corporate and project policies and procedures.

Supplier Quality Investigations Writer

Pfizer (Contract via Technical Source) - Rocky Mount, NC Apr. 2023-Mar. 2024

●Responsible for the initiation, investigation and processing of deviations in company Quality Management Systems (QMS).

●Created and tracked SCARS (Supplier Corrective Action Reports) by gathering data from various stakeholders and sources across large GMP site as well as third party vendors.

●Conducted in-depth interviews, gathered pertinent information determining root cause, writing product impact analysis statements in Veeva Vault.

●Advanced-level proficiency with MS Teams, Veeva, Vault, Trackwise, PMED, and Clinical Data Tracking Tools.

Quality Assurance Specialist, Technical Writer

Technical Resources International, Inc. (TRI) (Contract) - Bethesda, MD (Remote) Oct. 2021-Oct. 2022

●Conducted internal and external audits at clinical trial and vendor sites, verifying compliance to applicable Standard Operating Procedures.

●Reviewed all trial documentation for accuracy and adherence, including Protocol, Monitoring Visit Report forms, Informed Consents, Case Report Forms, drug supply, etc. Performed quality checks of study metrics such as site enrollment and selection and any deviation follow-up.

Medical Writing Support Coordinator

Parexel - Durham, NC Nov. 2017-Oct. 2021

●Generated and reviewed Quality Control (QC) checklists and regulatory documents while working in a Global Matrix environment.

●Meticulously tracked the lifecycle of document reviews, ensuring seamless coordination and timely receipt of internal and external review comments.

●Assisted in developing departmental SOPs.

●File documentation and maintenance in VEEVA Vault and PMED.

●Downloaded clinical trial data and triaged against ClinicalTrials.gov.

Clinical Project Specialist

Syneos Health (Formerly INC Research) - Morrisville, NC Jan. 2017-Sept. 2017

●Maintained study project plans and study information in a variety of databases and systems.

●Supported Clinical Team for assigned trials through project management of studies from planning through closeout including team meetings, status reports, materials, and presentation decks.

Sr. Clinical Project Administrator

Greenwich Biosciences (formerly GW Pharmaceuticals) - Raleigh, NC Oct. 2015-Oct. 2016

●Facilitated study-related activities including feasibility questionnaires, IVRS, drug supply, investigator and vendor meetings, database lock, etc.

●Visited sites to assist Clinical Research Associates CRAs with outstanding queries on Monitoring Visit Reports (MVRs).

●Performed audits of ISF and Pharmacy site binders.

●Served as the point of contact for the global team.

●Ordered supplies for study sites and shipped as needed using Randomization and Trial Supply Management (RTSM) platform to monitor study metrics and drug shipments.

●Supplies included binders for the Investigator Site File (ISF) and Pharmacy, envelopes for the Electronic Patient Reported Outcomes (ePROs), and ePRO pamphlets.

●Ordered Case Report Forms (CRFs), questionnaires, and diary booklets. Facilitated the archiving of study documents received from Clinical Research Associates (CRAs) electronically.

Sr. Clinical Trials Assistant

IQVIA (formerly Quintiles) - Durham, NC Feb. 2014-Sept. 2015

●Updated and maintained clinical systems and Trial Master File (TMF) within project timelines ensuring audit readiness.

●Distributed clinical trial supplies while serving as the central contact for the Clinical Team for project communications, regulatory documents, and associated correspondence during multiple phase I and II trials.

●Facilitated team meetings and reconciled meeting minutes.

U.S. Sr. Clinical Trials Associate

OV Clinical (formerly Medical Research Network) - Raleigh, NC Jun. 2012-Jan. 2014

●Adhered to integrated study plans for all study phases 1-4 (study start-up, execution and reporting).

●Facilitated delivery of equipment for clinical home trial support studies.

●Served as Point of Contact for U.S. nurses and vendors in a global network.

●Shipped supplies to nurses and tracked home visits in database via IVRS.

●Ensured equipment calibration during Phase III hematology study.

●Main point of contact for sponsors and vendors, ensuring oversight of trial execution while addressing issues in a timely manner.

●Facilitated meetings minutes & PowerPoint presentations using MS Office Tools (Powerpoint, Excel, Word).

Site Coordinator, Site Start-Up (SSU)

IQVIA (formerly Quintiles) - Durham, NC May 2008-Apr. 2010

●Identified and partnered with researchers to locate clinical sites for new trials through feasibility assessments.

●Maintained Study Start Up (SSU) tracking in Clinical Trial Management System (CTMS) and spreadsheets.

●Prepared site regulatory documents, reviewing for completeness and accuracy, and followed up as necessary.

Clinical Projects Associate, Data Entry Keyer

Copernicus Group IRB - Durham, NC May 2008-Apr. 2010

●Primary liaison to obtain required regulatory study related information.

●Performed accurate data entry for project tracking.

Prepared site regulatory documents, reviewing for completeness and accuracy, and followed up as necessary.

Coded relevant medical terminology, generating descriptive narratives.

Reviewed and forwarded queries pertinent to study cases.

Coordinated protocol translations as necessary ensuring delivery of reports within assigned deadlines.

Triaged operational data from various sources on time, within budget and per quality standards.

Assisted with reconciliation throughout project life cycle until closure.

Professional Development

●The Protection of Human Research Subjects - Good Clinical Practice, Collaborative Institutional Training Initiative (CITI) Program (2017–Present)

●The Protection of Human Research Subjects - Track 1 (biomedical), CITI Program (2017)

●Information Security and Management: Information Security, Counterintelligence, Privacy Awareness, Records Management, and Emergency Preparedness, National Institutes of Health (NIH) (2017–Present)

●Plain Language Training, NIH (2019)

●Section 508 Compliance Training, TRI (2017)

●Anti-harassment Training, NIH (2022)

●Implicit Bias Training, NIH (2022)

●Annual Global Ethics & Compliance Training (2025)

●U.S. Workplace Harassment and Discrimination Prevention for Promoted Supervisors and above (2025)

●Expanding Your Communication Skill Set (2025)

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