Jozette Smith
Summary
Dynamic Clinical Trial Specialist with extensive experience, excelling in eTMF management, and regulatory compliance. Proven track record in enhancing study start-up efficiency and maintaining inspection readiness. Adept at fostering team collaboration and delivering quality assurance, ensuring successful execution of Phase I-IV clinical trials. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Continuum Clinical Support (Contract)
Jozette Smith, LLC (Spectrum Science Communication, LLC)
03.2024 - 05.2025
- Managed inbound and outbound calls remotely, enhancing communication efficiency.
- Collected clinical trial participants' information to assess eligibility using approved scripts.
- Executed documentation systems to evaluate participant needs effectively.
- Facilitated collection of medical records through online portal for clinical trial participants.
Sr. Study Start-Up Specialist - Clinical Trial Assistant – SSU/CTA (Contract)
Cartis Clinical (ProSciento)
11.2023 - 06.2024
- Assisted the startup team with the planning, execution, and oversight of clinical trials in our CRO division.
- Assisted Sr. Director, Business Operations, with study start-up activities, that included study-specific form development, regulatory binder/investigator package set up and shipping, communications/correspondence, regulatory document submissions, and equipment / supply procurement.
- Assisted team with internal / external meeting coordination and generated meeting agenda/ minutes, during the startup phase.
- Managed workflow for confidentiality disclosure agreements (CDA) - reviewed, submitted, and executed study forms reviewed by client, regulatory document receipt, and eTMF documents uploaded, reviewed and approved.
- Contributed to the periodic review of study files for accuracy and completeness, during the startup phase.
- Assisted with upkeep of the clinical trial management system (CTMS) site database and sent feasibility questionnaires to new prospective investigators and/or sites that participated in specific projects and exported applicable study data for eTMF set up.
- Assisted the team with the selection of investigators, as well as with site issue resolutions.
- Worked with investigative sites and ad-hoc team members to complete all documentation necessary, during the startup process. Identified document types, classified and filed documents into eTMF (VEEVA).
Document Management Specialist – VEEVA (Contract)
ALKU (RezoluteBio)
02.2023 - 09.2023
- Reviewed and input historical technical documents into the new Veeva EDMS system including SOPs, forms, specifications, technical reports and eTMF documents from early clinical trials.
- Identified document types, classified and file documents into eTMF (VEEVA); document types included development reports, method developments, method validation, early clinical batch records and TMF documents.
Clinical Trial Administrator (Contract)
Advanced Recruiting Partners (Chiesi)
06.2022 - 02.2023
- Study Documentation: Prepared / assembled study documentation and supported the Clinical Project Manager in ensuring the compliance of the clinical trial with internal SOPs and regulations.
TMF Process Specialist
Alexion Pharmaceutical, Inc.
06.2021 - 06.2022
- Assisted with establishing and maintaining TMF monitoring and reporting.
- Delivered KPI reports to study team, managed expectations, and tracked ongoing KPI across study team in conjunction with the Clinical Trial Managers and Clinical Project Leads.
- Provided best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives.
- Supported integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
- Assisted with CRO eTMF configuration testing as needed.
- Assisted with TMF process education efforts.
- Provided process and planning support for the CTM and CPLs for TMF related remediation and process execution as needed.
- Proactively stayed current with best practices and recommended applications across portfolio to continuously improve TMF operations processes.
- Led projects in support of study or portfolio TMF objectives and attend standing cross functional meetings.
TMF Specialist (Contract)
EASI LLC / Actalent (Abbvie)
10.2019 - 06.2021
- Worked with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness
- Created and maintained study specific TMF Management Plans and indices
- Managed conduction of TMF quality reviews by cross-functional study team; driving to closure quality review findings
- Supported the functional owners in the identification and management of the collection of study specific TMF content, (where PCYC owned, and when delegated to vendor and/or CRO)
- Performed independently; day to day quality checks of TMF content and accuracy of coding
- Acted as TMF subject matter expert (SME)/ point of contact for study teams and TMF stakeholders
- Produced and managed site/ study / business level TMF reports and metrics provided to study teams who use the eTMF as the repository of their TMF records
- Managed and reconciled TMF records across multiple record management databases
- Performed inventory activities for off-site storage records
- Provided input on the revision of TMF related Work Instructions and SOPs
- Performed TMF oversight in the form of periodic risk-based quality checks on records reviewed by Clinical Records Administrators
- Provided support and TMF guidance in audits and/ or inspections
- June 2020: EASI STAR Award Recipient
Clinical Trial Assistant/Associate
Femassys – Suwanee, GA
Suwanee
06.2018 - 06.2019
- Provided Clinical Operations Team members with administrative and project-specific support related to the conduct of clinical trials.
- ETMF document transition – using SiteZone/Wingspan eTMF
- Essential / Site Document Tracking for study start-up; Vendor management, monitoring visits, Study enrollment
- Tracked monitoring reports / site visits: collected sponsor TMF documentation including IRB submissions and approvals and outstanding essential documents
- Maintained sponsor site lists, report weekly enrollments, CTMS users, managed new site activations, Manage Site Training logs, Site correspondence/communication
- ETMF Coordinator / site trainer
Clinical Research Coordinator
Winship Cancer Institute (Emory University) – Atlanta, GA
Atlanta
05.2017 - 09.2017
- Pre-screened and Consented subjects for eligible clinical trials; scheduled all qualifying ancillary appointments for eligibility criteria; captured all screening – screen fail information, consulted with Sponsor regarding study progress
- Interfaced with research participants, determines eligibility and consents study participants according to protocol
- Supervised collection of study specimens and processing
- Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires
- Established case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services
- Ensured compliance with research protocols, reviewed case report forms and audits for accuracy with source documents, attended monitoring meetings with sponsors
- Prepared regulatory submissions
- Coordinates services, schedules procedures, creates and maintains research records (eCRFs), and enters charges for patients in the web-based clinical research financial management database
- Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms
Clinical Trial Assistant / Associate
Aeras – Rockville, MD
Rockville
09.2016 - 04.2017
- Contributed to clinical study start-up, execution, closeout and reporting
- Collected, reviewed and tracked regulatory and other essential documents
- Interfaced with Investigators, CROs and other Vendors to support effective delivery of study sites and completeness and accuracy of related essential documents
- Served as main point person for all Trial Master File Documents, both electronic and paper
- Lead, initiated, tracked and maintained the Trial Master File ensuring ICH GCP compliance
- Served as eTMF system administrator, Subject Matter Expert and project leader for Aeras Veeva eTMF including managing system updates, training and on-boarding of internal and external staff and managing access control
- Acted as Subject Matter Expert on Trial Master File content and management
- Contributed to coordination and tracking of study and related supplies, equipment, and documents
- Planned and collated the administrative appendices to the final Clinical Study Report (e.g. List of Investigators, CVs; etc.)
- Coordinated administrative tasks during study conduct, audits and regulatory inspections according to company policies and SOPs
- Prepared, contributed to, updated and / or distributed material for meetings, newsletters and websites
- Lead logistical arrangements of internal and external meetings, both telephonic and face to face meetings, including preparing agendas and minutes
- Supported with travel and other logistics arrangements for study related travel for study team members as needed
- Supported study team with management and updates to study timelines as needed
- Supported study team with financial management of clinical trials including tracking, reviewed and processed invoices
Clinical Data Assistant (Contractor)
The Select Group (Quintiles / Q2) – Marietta, GA
Marietta
09.2014 - 09.2016
- Provided support to QATL Lab Data Management; analyzed, tracked and updated test code metrics as part of upcoming pricing tool
- Completed DCR requests for research data creation and modifications to existing and new test codes; updated in-house systems with updated metadata
Franchise Owner (Quizno’s Restaurant)
A&J Ventures, Inc. – Douglasville, GA
Douglasville
04.2014 - 07.2015
- Spearheaded all administrative paperwork associated with opening new restaurant (franchise corporation training, restaurant logistics, licenses, and permits)
- Interviewed, hired, and trained all new hire employees; completed inventory management by replenishing and placing food orders
- Completed day-to-day transactions and conducted follow up and on the spot training for employees to improve efficient operations
- Completed all administrative paperwork associated with opening new restaurant (Franchise corporation training, restaurant logistics, licenses, and permits)
- Operations Manager – interviewed, hired, and trained new employees
- Inventory management – place food orders, associated inventory
- Manager / Supervisor – completed day-to-day transactions, employee training and oversight
Clinical Trial Assistant/CRA
FibroGen Inc. – San Francisco, CA
San Francisco
09.2013 - 04.2014
- Created / maintained Central Trial Master Files (TMFs)
- Managed regional site as CRA1
- Arranged meetings / travel
- Drafted / distributed meeting agendas and minutes
- Initiated purchase orders and maintain inventory of clinical supplies
- Processed invoices and maintain payment file; leases with Clinical Contract & Outsourcing (CC&O) as needed
- Ordered / shipped supplies to study sites / CRO’s
- Processed drug shipments, returns and assist with in-house drug reconciliation
- Assisted in preparation of regulatory binders, study and/or pharmacy manuals
- Draft / distributed clinical meeting presentations upon request
- Reviewed regulatory documents prior to submission to Regulatory Affairs
- Participated in investigator meetings
- Assisted in review of relevant documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
- Assisted in study implementation
- Assisted in preparation of safety, interim and final study reports
- Assisted in resolution of data discrepancies; interact with data management to acquire listings
- Communicated directly with study site personnel in relation to study supplies, enrollment, tracking and subject visits, etc.
Clinical Research Assistant (Contractor)
InVentiv Health (Nektar Therapeutics) – San Francisco, CA
San Francisco
04.2013 - 09.2013
- Assisted Regulatory Department with IP excursions – tracked, documented & responded to excursions per SOP
- Provided support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval
- Performed general administrative functions such as, scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/ contracts from CROs, budget tracking and helps to ensure payments are on time
- Performed data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
- Set-up/maintained study & Clinical Operations files for assigned clinical trials
- Maintained essential clinical docs / business with CRO, Vendors, other Departments & partnership collaborations
Ombudsman
US Navy – Denver NOSC – Denver, CO
Denver
04.2012 - 04.2013
- Liaison between Chief Operations Commander and military families
- Offered family resources assistance / support
- Conducted regular Ombudsman Program Information Seminars on Training Weekend
- Created & distributed Monthly Ombudsman Newsletters
Clinical Trial Assistant / CRA, Clinical Operations
Onyx Pharmaceutical – S. San Francisco, CA
San Francisco
08.2008 - 10.2011
- Created/maintained Sponsor TMF
- Scheduled/facilitated weekly internal Dept & CRO meetings
- Meeting agendas / minutes & TMF filing
- Created TMF outstanding document lists for site CRAs
- Co-Monitored site close-out visits
Education
Bachelor of Science - Health Administration
Southern New Hampshire University
Hooksett, NH01-2027
Technical Certificate - Travel & Airlines
Condie Jr. College
Campbell, CA12-1989
Skills
- eTMF management: VEEVA, PhlexGlobal, WingSpan, ELVIS, Trial Interactive
- Certified VEEVA Vault administrator
- TMF administration
- eCRF review
- CTMS expertise
- Essential documents review
- Close-out monitoring
- Clinical trials: Phase I-IV
- Oncology specialization
- Regulatory affairs knowledge
- CRO liaison skills
- Vendor management
- Study start-up expertise
- Remote and hybrid work experience
- Clinical trial management
- Regulatory compliance
- Team collaboration
- Multitasking skills
- Microsoft Office proficiency
- Quality assurance
- Document management
- Task prioritization
- Dependable and responsible
- Effective communication
- Organizational skills
- Flexible and adaptable
Certification
- Certification, Association of Clinical Research Professionals (ACRP), Certified Professional
- Certification, Medidata Rave Clinical Research Coordinator
- VEEVA Vault Administrator Training Certificate – Veeva Training Center
- Certificate, Clinical Research Conduct and Management; UC Berkeley-Extension
References
Provided upon request
Timeline
Continuum Clinical Support (Contract)
Jozette Smith, LLC (Spectrum Science Communication, LLC)
03.2024 - 05.2025
Sr. Study Start-Up Specialist - Clinical Trial Assistant – SSU/CTA (Contract)
Cartis Clinical (ProSciento)
11.2023 - 06.2024
Document Management Specialist – VEEVA (Contract)
ALKU (RezoluteBio)
02.2023 - 09.2023
Clinical Trial Administrator (Contract)
Advanced Recruiting Partners (Chiesi)
06.2022 - 02.2023
TMF Process Specialist
Alexion Pharmaceutical, Inc.
06.2021 - 06.2022
TMF Specialist (Contract)
EASI LLC / Actalent (Abbvie)
10.2019 - 06.2021
Clinical Trial Assistant/Associate
Femassys – Suwanee, GA
06.2018 - 06.2019
Clinical Research Coordinator
Winship Cancer Institute (Emory University) – Atlanta, GA
05.2017 - 09.2017
Clinical Trial Assistant / Associate
Aeras – Rockville, MD
09.2016 - 04.2017
Clinical Data Assistant (Contractor)
The Select Group (Quintiles / Q2) – Marietta, GA
09.2014 - 09.2016
Franchise Owner (Quizno’s Restaurant)
A&J Ventures, Inc. – Douglasville, GA
04.2014 - 07.2015
Clinical Trial Assistant/CRA
FibroGen Inc. – San Francisco, CA
09.2013 - 04.2014
Clinical Research Assistant (Contractor)
InVentiv Health (Nektar Therapeutics) – San Francisco, CA
04.2013 - 09.2013
Ombudsman
US Navy – Denver NOSC – Denver, CO
04.2012 - 04.2013
Clinical Trial Assistant / CRA, Clinical Operations
Onyx Pharmaceutical – S. San Francisco, CA
08.2008 - 10.2011
Bachelor of Science - Health Administration
Southern New Hampshire University
Technical Certificate - Travel & Airlines
Condie Jr. College
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