Summary
Overview
Work History
Education
Skills
Certification
Related Work Experience
Technical Skills
Timeline
OfficeManager
Trellis Frierson

Trellis Frierson

Durham,NC

Summary

Professional with extensive experience in a variety of research fields as a Study Start Up (SSU) Associate, Associate SSU Manager, Vendorx Manager, Research Assistant, Labeling Specialist, Regulatory Affairs Specialist, In House CRA and Project Coordinator with extensive healthcare, clinical trials, regulatory compliance, and safety experience in CRO, federal government, IRB, and academic research settings with experience and knowledge in project coordination, site activation, study start up, data management, management with phase I-IV clinical trials. Experience in CNS, dermatology, cardiology, hematology, oncology, neurology, respiratory, medical device, women’s health, rare disease, gastrointestinal and immunology global trials; and providing administrative and operational support for sponsor and CRO responsible for project management, study start up and clinical operations.


Responsible for the efficient preparation of high-quality, strategically aligned deliverables that support the clinical development, safety, and regulatory requirements submissions and working knowledge of and experience in document management systems.

Detail-oriented and driven team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Hardworking and passionate job seeker with strong organizational skills eager to secure senior level Project Manager opportunity. Ready to help team achieve company goals. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals,and professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Regional Site Activation Project Manager

IQVIA
05.2022 - Current
  • Facilitates the life-cycle of controlled documents in the electronic document management system (document creation, revision and obsoleting)
  • Fully executes and negotiates compensation and legal Ikformed Consent Language, Confidential Disclosure, Letter of Intent, Memoranda of Understanding
  • Escalate issues regarding financial andbudget appendix as needed to sponsor
  • Serve as point of contact regarding country level Regulatory and Ethics Committee submissions packages EC review and approval on behalf of sponsors
  • Executes cGMP standard operating procedures while adhering to all company quality standards and requirements for North America Regulatory Authorities, including FDA and Health Canada
  • Executes and assess for accuracy and process Document Change Request TMF workflows
  • Demonstrate expertise in Microsoft Word and other Microsoft Office applications to meet established document formatting requirements
  • Executes and provide coaching and mentoring for entry level team members
  • Works under the guidance an supportof Project Managers, Project Leads, Regulatory Advisor, Country Heads and Global Site Activation Managers
  • Manages external requests for country specific labeling information (e.g
  • Medical content, pharmaceutical properties) from various source or reference documents
  • Notifies appropriate groups or changes or recent source/reference labeling approvals
  • Prepares country-specific labeling in support of safe and appropriate use of products for in-scope countries; maintains country specific translation mastercopy to meet labeling responsibilities
  • Prepares, tracks, maintains and reviews required labeling documents (e.g
  • Physician’s label, patient insert, carton, label, blister, tenders) using Text verification Tools, and additional software or process tools to maintain change history for all labeling documents
  • Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation
  • Provides input and drives the development of new dashboards or metrics
  • Provides Project Team and Cross-functional area support to streamline and enhance current data review processes associated with clinical operations and development
  • Creates, maintains and manages reporting and visualizations to be used for projects
  • Works with project teams to implement and/or update reports, or create new reports as needed to ensure project-specific requirements are met
  • Supports Leadership to ensure operational intelligence oversight, coordination and development of clinical trial operations analytics (e.g., trial feasibility analysis, geography, site selection, smart metrics, analytical insight and actionable recommendations)
  • Provides frequent input to BDU Leadership and/or Clinical Management Teams on newly identified trends and/or reporting
  • Performs and/or has oversight of clinical trial lay language summary activities for drug, device, registry and biologic clinical trials including: receiving/reviewing documents, assessing requirements, authoring/reviewing plain language summaries, managing data entry on multiple global and local registries, performing quality control functions, maintaining document archive upon completion
  • Review of feedback from multiple sources
  • Notes trends of site activation and site management activities
  • Provides input and drives the development of new dashboards or metrics
  • Provides Project Team and Cross-functional area support to streamline and enhance current data review processes associated with clinical operations and development,agreements and amendments
  • Prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics
  • Works in close collaboration with the Site Mangers ( CRA )and the Local Study Team/Local Study Associate/Project Manager/Clinical Lead to ensure that study start-up activities and milestones are achieved in a timely and efficient manner in accordance with sponsor requirement and company SOPs.
  • Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
  • Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
  • Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
  • Actively participates in Local Study Team (LST) meetings.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Reported regularly to managers on project budget, progress and technical problems.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Analyzed project performance data to identify areas of improvement.
  • Sourced, vetted and managed vendors needed to accomplish project goals.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Proven ability to learn quickly and adapt to new situations.
  • Self-motivated, with a strong sense of personal responsibility.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Worked effectively in fast-paced environments.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Excellent communication skills, both verbal and written.
  • Passionate about learning and committed to continual improvement.
  • Strengthened communication skills through regular interactions with others.
  • Organized and detail-oriented with a strong work ethic.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Developed and maintained courteous and effective working relationships.
  • Identified issues, analyzed information and provided solutions to problems.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Paid attention to detail while completing assignments.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Worked flexible hours across night, weekend and holiday shifts.
  • Worked well in a team setting, providing support and guidance.
  • Skilled at working independently and collaboratively in a team environment.

Global Vendor Project Manager

Q² Solutions
03.2021 - 05.2022
  • Facilitated seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs
  • Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation
  • Will prepare and present protocol-specific materials at Kick Off and Investigator meetings
  • Leads Vendor bid defense meetings
  • Manages the contract negotiation process for complex or high value contracts
  • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development
  • Is project focused and works with a sense of urgency
  • Understood, analyzed and developed recommendations from multiple complex sources such as financial and operational perspectives
  • Influenced vendor selection with stakeholders at the project team level
  • Identifieed developed, and deployed best practices in vendor selection, cost containment, and category management practices
  • Leverageed prior experience with external benchmarking, industry best practices, and technology for continuous improvement
  • Took ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness
  • Triaged study-level vendor management issues; escalates high-risk issues to appropriate stakeholders
  • Translated trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up
  • Engaged with study team leadership to drive sourcing strategy, compliance, and continued partnership
  • Exhibited competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
  • Partnered with internal stakeholders working on services required for the protocol were included in the study materials ( e.g
  • Plasma, CK, Biomarker, Urine, Blood Chemistry, Panels, etc.), including shipment, storage, analysis and receipt from investigator sites and other laboratories based on the study’s laboratory specifications
  • Assisted in preparation of FDA 1572 and other regulatory documents by providing information regarding laboratory locations for regulatory submissions, quality/vendor audits and regulatory authority inspections such as EMEA and/or FDA
  • Collaborated with Senior Project Leadership and Business Development group to develop and strengthen strong relationships with current sponsors to generate new and/or add-on business for the future
  • Worked to ensure that all project deliverables meet the customer’s time/quality/specifications/cost expectations
  • Ensured projects adhere to design controls and other applicable standards and analyze, manage and escalate risks to enable successful project completion
  • Analyzed progress and, when necessary, seeks approval for changes to planned scope, timelines, and costs to ensure that projects meet requirements of study protocol and adhere to company standards
  • Defined and built processes and tools; cultivates resourcing and strategies for effective study development and project management
  • Develops appropriate supply chain strategy to maximize customer satisfaction at the lowest possible cost
  • Planned, managed and coordinated all activities related to the sourcing and procurement of necessary materials, kits and supplies needed to meet the changing levels of product demand
  • Worked with Materials Management, Warehouse, Shipping and Logistics Departments to determine and set up intercompany and external transfers
  • Monitored inventory levels at outside warehouses (3PL) and internally to ensure rotation is sufficent for study needs.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Reported regularly to managers on project budget, progress and technical problems.

Site Start Up Specialist I

Apex Systems
09.2020 - 02.2021
  • QC'd site documents, reviewed for completeness and accuracy
  • Ensured accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
  • Reviewed and provided feedback to Senior Site Specialist on site performance metrics
  • Inform team members of completion of regulatory and contractual documents for individual sites
  • Reviewed, tracked and follow up the progress, of essential regulatory documents from sites
  • Report updates of regilatorydocimentd to local site to Senior Site Specialist and project team for on-going project timeline planning and close out of site
  • Followed up with Clinical Research Associates on pending regulatory essential documents from site for maintenance of Trial Master File , and for Senior
  • Site Specialist reporting to sponsor during meetings.

Senior Clinical Trials Administrator

Covance
11.2019 - 09.2020
  • Followed up study team or Sponsor requests for clarifications, supplementary information
  • Reviewed patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Work Instructions, Data Entry Guides/Validation Manuals (DRGs/DVMs) within their allocated studies.
  • Identified data issues and works with team and study sites to resolve
  • Assisted with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed
  • Assisted the SRP with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
  • Supported investigator sites, SRPs, Study Managers and study teams in preparation for and providing responses to site audits/inspections
  • Attended Sponsor, Investigator and CRA meetings and use meeting recordings to prepare draft minutes; prepares and distributes agenda for Sponsor and Project Teams within agreed timelines
  • Recorded questions and answers, and coordinates with the staff to ensure smooth running of the meeting
  • Proofread and edit final minutes to ensure accuracy and finalization within required timeframe based on Communication Plan guidelines; management of final minutes and agenda in Trial Master File according to TMF archiving plan
  • Served as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
  • Assisted in the coordination and planning of Investigator, Vendor Training, Internal and External sponsor meetings
  • Distributed and filed SUSAR reports
  • Assisted preparation in for CRO to sponsor transfer of TMF archive, sponsored external and internal quality/vendor audits and regulatory authority inspections such as EMEA and/or FDA
  • Provide and remove user access from project systems
  • Track training compliance and update training plans for project specific documents
  • Prepare, handle and distribute of Clinical Trial Supplies and maintenance of tracking information
  • Assists with preparation for planned and unannounced audits.
  • Managed protocols relating to human subjects research and collection and processing of human samples procured under auspices of NIH IRB-approved clinical research protocols.
  • Collaborated with team members to comprehend operational demands and manage resource allocation.
  • Translated data collection needs into clinic-side standards and tools, collaborating with resources beyond intramural setting.
  • Enforced proper techniques for protection of human subjects, conflict of interest guidelines and patient confidentiality.
  • Offered expertise to technicians on obtaining and maintaining laboratory certifications.
  • Analyzed data, publishing and presenting findings elucidating trends and implications within professional networks and periodicals.
  • Applied sound judgment and clinical expertise in situations lacking established guidelines to inform treatment protocols.
  • Complied strictly with IRB, NIH and federal regulations governing human subjects research.
  • Resolved issues through active listening and open-ended questioning, escalating major problems to manager.
  • Coordinated individual duties after careful evaluation of each employee's skill level and knowledge.
  • Oversaw appointment scheduling and itinerary coordination for both clients and personnel.
  • Organized meetings for executives and coordinated availability of conference rooms for participants.

Site Activation Lead

Worldwide Clinical Trials
12.2018 - 06.2019


  • Served as primary point of contact and liaison with investigative sites during feasibility, study start-up/ site start-up (SSU) activities, processes and amendment management, study maintenance when assigned on allocated projects with Principal Investigator and site staff
  • Performed internal data review, query resolution, and cleaning of data based on programmed edit checks and assisted Data Manager in reviewing data on a regular basis looking for inconsistencies
  • Obtained, tracked, maintained current study insurance certificates to include in Investigator Product Package for greenlight
  • Assembled information regarding translation of informed consent, recruitment materials and study documents from various central and local IRB vendors, clinical supplies for site activation and start up; coordinated completion of translations once vendor approval process completed
  • Managed support of local investigative sites and country level regulatory in preparation and submission for Ethics Committee and Health Authorities including follow up through approval of initial reviews, continuing reviews, amendments, safety notifications and any other documentation requiring submission to Health Authorities
  • Collaborated cross-functionally with global team members to ensure site activation success and present risk mitigation strategies at executive-level meetings
  • Communicated with investigative sites and internal team members to forecast timelines for site activation and ensure all activation requirements are met
  • Delivery of feasibility site investigative site list in conjunction with PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial
  • Collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team
  • Oversaw the execution of all start-up related activities through last site activated according to study strategy
  • Collaborate cross-functionally with global team members to ensure site activation success and present risk mitigation strategies at executive-level meetings
  • Exhibited the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks.

Administrative Associate II

Temp Solutions State Of North Carolina
11.2018 - 12.2018
  • Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
  • Edited documents to improve accuracy of language, flow, and readability.
  • Restocked supplies and submitted purchase orders to maintain stock levels.
  • Updated spreadsheets and databases to track, analyze, and report on performance and sales data.

Project Coordinator II/In House CRA

Health Decisions
11.2016 - 05.2018


  • Collaborated with internal and external customers to meet project specific goals including participation in sponsor and project related meetings.
  • Acted as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals.
  • Identifies, monitors, documents, and tracks out-of-scope activities.
  • Supported Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
  • Assisted with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution via EDC.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
  • Submitted routine status reports and follow-up letters to facilitate internal and external communication.
  • Interfaced with clinical investigators and site staff to foster ethical research consistent with research plan and to identify, assess and resolve site performance, quality and compliance issues.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical teams.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Conducted meetings with sponsor representatives to discuss clinical study developments.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
  • Created and maintained database and records filing system to document data on specimen collection, processing and storage.
  • Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
  • Applied extensive clinical research knowledge to troubleshoot and resolve regulatory document issues.
  • Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
  • Leveraged knowledge, expertise and problem-solving techniques to resolve investigative site issues.
  • Liaised with Cross Functional department personnel to communicate important clinical data and events.
  • Set up and disbanded trial study centers to manage clinical study activities for 25 sites.
  • Answered questions and provided guidance during course of clinical study.
  • Followed informed consent processes and maintained records.
  • Collected, evaluated, and modeled collected data.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

Education

Associate of Science Environmental - Health, and Safety Technology

Durham Technical Community College
Durham, NC

American Society of Quality Certificate in Quality Improvement Associate -

Calhoun Community College

Certificate in Total Quality Management -

Fayetteville Technical Community College

Skills

  • Project Management and Data Management principles
  • Experience in project/vendor management, quality improvement, IRB, regulatory and study start-up
  • FDA, ISO, cGMP, cGCP, cGLP and regulatory terminology
  • Strong documentation skills Scheduling/Inventory/Vendor Management
  • Management of approximately 50-150 sites in regulatory activation per FTE and resource allocation
  • Quality Assurance/Auditing principles
  • GxP Regulations
  • ICH Guidelines,
  • Good Quality Practices
  • 21 CFR Part 11 and Computer Security Part 11, Electronic Records; Electronic Signatures-Scope and Application;
  • HIPAA
  • Drug Development and Approval Process

Certification

BioWork Process Product Development Certified Process Technician (CPT) Good Clinical Practice Certification (GCP)

Related Work Experience

11/2018-12/2018

Temp Solutions/North Carolina Department of Public Safety - Division of Juvenile Justice/CS - District 14, Durham, NC Administrative Associate II ( contract)


11/2016 – 5/2018

Health Decisions, Durham, NC Project Coordinator II/In-House Clinical Research Associate I ( IHCRA)



11/2015 - 09/2016

Novella Clinical (a Quintiles Company), Morrisville, NC Investigator Site Start up Associate


10/2015 - 01/2016

AW, Durham, NC Occupational Safety Intern


12/2014 - 10/2015

Burt’s Bees, Durham, NC Labeling Specialist Regulatory Affairs Analyst ( contract)


04/2014 - 12/2014

Duke Clinical Research Institute Durham, NC /Clinical Trials Assistant II


08/2013 – 11/2015

Patient Centered Outcomes Research Institute, Washington, DC Patient Representative


04/2012 - 02/2014

PAREXEL International, Durham, NC /Research Operations Assistant


01/2012 - 03/2012

Kelly Services @ Duke Asthma Allergy and Airway Center, Durham, NC Clinical Trials Assistant I

( Contract )

10/2011 - 01/2012

Campbell University Clinical Research Center, Buies Creek, NC Project Coordinator (Contract)



08/2009 - 09/2011

United States Department of Veterans Affairs, Durham, NC Program Support Assistant (IRB)

Technical Skills

WebEx/Skype/MS Teams/Zoom/GotoMeeting/Teleconference Software Systems

MS Office (Word/Access/Outlook/Excel/PowerPoint/SharePoint)/Conference Planning/Database Software

Electronic Data Capture (LiveTrial, Medidata RAVE, InForm, TrialMaster)

Electronic Signature ( DocuSign, Veeva Vault Authoring/e-Signature)

Electronic Medical Record Software/Clinical Trials Management Systems (CTMS, goBalto, IMPACT Harmony Drug Dev)

Electronic Trial Master File (eTMF) (Veeva Vault, Wingspan, PMED, Conduit, PhlexGlobal)

Risk Based Monitoring/Management/Study Reporting ( XRIM, Xcellerate Portal, Project Web Tool, Regulatory Information Database/Power BI/Clinical Analytics)

Grants/Contract Management ( Investigator Payment Portal)

Project Management (MS Project/Trello)

Translation/Document Management/Publishing (Transperfect/RWS/Docs24)

Timeline

Regional Site Activation Project Manager

IQVIA
05.2022 - Current

Global Vendor Project Manager

Q² Solutions
03.2021 - 05.2022

Site Start Up Specialist I

Apex Systems
09.2020 - 02.2021

Senior Clinical Trials Administrator

Covance
11.2019 - 09.2020

Site Activation Lead

Worldwide Clinical Trials
12.2018 - 06.2019

Administrative Associate II

Temp Solutions State Of North Carolina
11.2018 - 12.2018

Project Coordinator II/In House CRA

Health Decisions
11.2016 - 05.2018

Associate of Science Environmental - Health, and Safety Technology

Durham Technical Community College

American Society of Quality Certificate in Quality Improvement Associate -

Calhoun Community College

Certificate in Total Quality Management -

Fayetteville Technical Community College

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