TASHAWN S. CLIFTON

ad3t93@r.postjobfree.com 984-***-****

Summary

An experienced In-House CRA/Clinical Trial Associate/TMF Specialist with demonstrated history of working in the global CRO and Sponsor Industry. Skilled in ICH Guidelines, Clinical Monitoring, Clinical Site Management, TMF and eTMF, Time Management and Customer Service coupled with proven ability to function well under pressure. I have over 20 years of experience in the clinical research field and I'm passionate about improving the health of the population.

Skills

Society of Clinical Research Associates

Member (SOCRA)

Professional skills

Microsoft Office Suite

Filing/Editing

Accounting

Microsoft Windows

Typing (53+ wpm)

Customer Service Skills

Microsoft Office Outlook

Office Procedures

Database Management

Lotus SmartSuite

Telephone Skills

Meeting Minutes

Lotus Notes

Transcription

Compass

CTMS (Bioclinica)

eTMF (Trial Interactive, Veeva, Wingspan,

Montrium)

DMNet (Data Management, Data Entry,

OpenClinica Network)

Monitoring Visits

Team Training

Detailed Documentation

Trial Oversight

Trip Reports

Clinical Documentation

Coordinating Supplies

Site Management

Research and Development

Scheduling Proficiency

Interdepartmental Collaboration

People Skills

Team Building

Problem Resolution

Supervision & Leadership

Relationship Building

Status Reporting

Data Evaluation

Experience

ICON RTP, NC

In-House CRA III

01/2022 – 05/2023

Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked

Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines

Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements

Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete

Documents site and Sponsor contact and study interactions in a timely and professional manner

Assists with resolution of investigational site/data queries

Liaises with project team members regarding study site issues

Provides quality review of the informed consent template

Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study

Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments

Performs other duties as assign

Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings

Acts 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

Supports 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

Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution to/from investigational sites

Proficient in the development and review of Informed Consent Form templates

May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents

Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the SUL/CTM

Supports the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects managed by ICON

Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions

Supports CTM/SUL/CRA in the management of clinical budget and evaluation of study processes

Evaluates metric data to identify process improvements

Assists with managing and training staff

Manages time and project requirements based on study contract

Brio Group Durham, NC

Trial Master File Specialist

08/2021 - 11/2021

Review of study and site documents for completeness and accuracy for inclusion into the eTMF

Good Knowledge of TMF documents

Able to identify document artifacts as per DIA reference model

Identified metadata required for the artifact and able to check and fill the correct metadata as per document types

Performed quality checks of the documents as per the SOP

Hands on knowledge on cloud based TMF repository as Montrium

Categorized the documents as per Study/Country/Site level

ICH-GCP knowledge

Communicating any issues, queries with Trial Document Manager and acting on the resolution

G1 Therapeutics RTP, NC

Clinical Trial Assistant

07/2018 - 02/2020

Veeva eTMF Subject Matter Expert – review of study, country, and site documents for completeness and accuracy for inclusion into the eTMF; build structure and maintain the eTMF; evaluate progress through reports and reconciliations, determines gaps, follows up with internal and external functions to ensure maintenance of the eTMF and propose solutions to resolve/document eTMF non-compliance

Direct/back-up support to the Clinical Operations Leaders, Study Team Project Leaders, CRAs and Clinical Operations study teams

Laboratory Sample Management

Country/Site insurance coverage management

Track study and program progress

Collection and filing of essential study and program documents

Direct communication with CRO teams and third-party vendors

Review new and revised FDA 1572s

ICF review

Records and compiles minutes from study team meetings

Updates and maintains tracking logs

FHI 360 Durham, NC

Clinical Trial Associate II

03/2015 - 07/2018

Provides support to the Technical Monitor, Project Manager and team members of assigned projects during any and all phases of the project (planning, development, initiation, monitoring, and reporting

Assists with completion of relevant Clinical Trial Management System (CTMS) fields, tracking tools, timelines, project plans and milestones with project specific information

Acts as a central contact for the clinical research sites for designated project communications, correspondence and associated documentation

Conducts Pre-study, Initiation, Interim and Closeout monitoring visits

Conducts on-site trainings

Conducts routine on-site Clinical Monitoring visits at clinical labs analyzing specimen data

Completes accurate monitoring visit reports

Conducts in-house routine temperature monitoring for specimen samples and investigational product

Assists in the preparation and development of essential study documents

Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial

Assures currency of required clinical trial documents within the Trial Master Files and the Electronic Trial Master Files (i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure, etc.) throughout the clinical trial

Maintains project specific regulatory documents inventory systems

Track and review essential regulatory documents from the sites

Coordinate ordering, dispatch and tracking of trial material

Coordinate document translation

Assist with scientific and ethical approval procedures

Assist with in-house monitoring of study progress and data quality

Assist with in-house data review

Download electronic study data to specified databases

Track data transmissions and downloads

Download, log and proof transcripts sent from sites

Update task list to include the review and the rapid analysis of data

Review of study files periodically for accuracy and completeness

Tracks and logs Serious Adverse Events (SAE)

Tracks and logs Protocol Violations (PVs)

Prepares and gathers documents for IRB submissions including informational items

Review and compares original English study document versions to back translated study document versions

Tracks and logs participant enrollment for clinical study sites

Assists with tracking study budgets for assigned studies

Prepares minutes for meetings and follow up with staff members for action items

Assists in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals

Assist management with potential new hire selection and shadowing process

70% Domestic and International travel required

FHI 360 Durham, NC

Research Assistant II

07/2010 - 02/2015

Provided support to the Technical Monitor, Project Manager and team members of assigned projects during any and all phases of the project (planning, development, initiation, monitoring, and reporting)

Conducted routine on-site Clinical Monitoring visits

Completed accurate monitoring visit reports

Assisted the Clinical Project Management team with all aspects of study management

Assisted in the preparation and development of essential study documents

Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Coordinated with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial

Assured currency of required clinical trial documents within Central Files (i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure, etc.) throughout the clinical trial

Maintained project specific regulatory documents inventory systems

Tracked and reviewed essential regulatory documents from the sites

Coordinated ordering, dispatched and tracking of trial material

Coordinated document translation

Assisted with scientific and ethical approval procedures

Assisted with in-house monitoring of study progress and data quality

Assisted with in-house data review

Downloaded electronic study data to specified databases

Tracked data transmissions and downloads

Downloaded, logged and proofed transcripts sent from sites

Updated task list to include the review and the rapid analysis of data

Reviewed of study files periodically for accuracy and completeness

Tracked and logged Serious Adverse Events (SAE)

Tracked and logged Protocol Violations (PVs)

Prepared and gathered documents for IRB submissions including informational items

Reviewed and compared original English study document versions to back translated study document versions

Tracked and logged participant enrollment for clinical study sites

Participated in various clinical monitoring staff meetings, team project meetings, and training sessions

Assisted with tracking study budgets for assigned studies

Stayed abreast of information and any changes to study protocol

Prepared minutes for meetings and follow up with staff members for action items

Assisted in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals

Assisted with production of participant binders of a clinical trial study

Assisted in the preparation, editing, and formatting of study related documents and other scientific writings and reports

Assisted with organization of meetings and special events

Coordinated travel arrangements for team and assigned staff, overseeing travel authorizations and expense reports, reviewing trip reports for content and format

Assist management with potential new hire selection and shadowing process

50% Domestic and International travel required

FHI Durham, NC

Research Assistant

10/2009 - 07/2010

Provided administrative support to the Technical Monitor, Project Manager and team members of assigned projects during any and all phases of the project (planning, development, initiation, monitoring, and reporting)

Assisted the Clinical Project Management team with all aspects of study management

Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Coordinated with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial

Assured currency of required clinical trial documents within Central Files (i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure, etc.) throughout the clinical trial

Maintained project specific regulatory documents inventory systems

Tracked and reviewed essential regulatory documents from the sites

Coordinated ordering, dispatch and tracking of trial material

Coordinated document translation

Assisted with scientific and ethical approval procedures

Assisted with in-house monitoring of study progress and data quality

Assisted with in-house data review

Downloaded electronic study data to specified databases

Tracked data transmissions and downloads

Reviewed study files periodically for accuracy and completeness

Tracked and logged Serious Adverse Events (SAE)

Prepared and gathered documents for IRB submissions including informational items

Reviewed and compared original English study document versions to back translated study document versions

Tracked and logged participant enrollment for clinical study sites

Participated in various clinical monitoring staff meetings, team project meetings, and training sessions

Assisted with tracking study budgets for assigned studies

Stayed abreast of information and any changes to study protocol

Prepared minutes for meetings and follow up with staff members for action items

Assisted in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals

Assisted with production of participant binders of a clinical trial study

Assisted in the preparation, editing, and formatting of study related documents and other scientific writings and reports

Assisted with organization of meetings and special events

Coordinated travel arrangements for team and assigned staff, overseeing travel authorizations and expense reports, reviewing trip reports for content and format

10% Domestic and International travel required

FHI Durham, NC

Administrative Assistant

10/2007 - 10/2009

Provided administrative support to the Technical Monitor, Project Manager and team members of assigned projects during any and all phases of the project (planning, development, initiation, monitoring, and reporting)

Assisted the Clinical Project Management team with all aspects of study management

Coordinated with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial

Assured currency of required clinical trial documents within Central Files(i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure, etc.) throughout the clinical trial

Maintained project specific regulatory documents inventory systems

Reviewed study files periodically for accuracy and completeness

Prepared and gathered documents for IRB submissions including informational items

Participated in various clinical monitoring staff meetings, team project meetings, and training sessions

Assisted with tracking study budgets for assigned studies

Stayed abreast of information and any changes to study protocol

Prepared minutes for meetings and follow up with staff members for action items

Assisted in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals

Assisted with production of participant binders of a clinical trial study

Assisted in the preparation, editing, and formatting of study related documents and other scientific writings and reports

Assisted with organization of meetings and special events

Performed other duties as assigned

Coordinated necessary arrangements for international visitors, including travel logistics, meetings with divisional staff and other organizations

Coordinated travel arrangements for team and assigned staff, overseeing travel authorizations and expense reports, reviewing trip reports for content and format

For final versions, types, formats, edits correspondence, papers, reports, proposals, subagreements, purchase requisitions, and other written work generated by assigned staff members

Composed general correspondence, schedules and memoranda as needed

Organized and set-up internal meetings

Education and Training

FHI 360 Durham, NC

Research Ethics Certificate

07/2017

FHI 360 Durham, NC

Certificate in GCP For Clinical Trials

07/2016

FHI 360 Durham, NC

Certificate in PMD Pro

03/2014

Chapel Hill High School Chapel Hill, NC

Diploma

Durham Technical Community College Durham, NC

Clinical Trials Research Associate Level 1 Certificate; Still Attending

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