Customer Service Support

TASHAWN S. CLIFTON

Email: ad5wsz@r.postjobfree.com Telephone Number: 984-***-****

Summary

Solution-oriented Customer Service Specialist with years of experience in the Healthcare environment. Providing efficient, quick, and friendly service to customers and patients as well as building strong relationships with them. It also entails responding to customers' issues in a timely manner and handling any complaints promptly. Known for improving customer satisfaction through clear communication and deep understanding.

Skills

• Society of Clinical Research Associates

Member (SOCRA)

• Professional skills

• Microsoft Office Suite

• Filing/Editing

• Accounting

• Microsoft Windows

• Calendar Management

• Typing (53+ wpm)

• Customer Service Skills

• Microsoft Office Outlook

• Office Procedures

• Database Management

• Lotus SmartSuite

• Costpoint

• Telephone Skills

• Meeting Minutes

• Lotus Notes

• Transcription

• Compass

• CTMS (Bioclinica)

• eTMF (Veeva, Trial Interactive, Wingspan, Montrium)

• 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/PRA Health Sciences RTP, NC

In-House CRA III

06/2022 – 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 ICON/PRA Health Sciences RTP, NC

In-House CRA II

01/2022 – 06/2022

• 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 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

• 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

• 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

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

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

• Regulatory Compliance and Documentation: Coordinate the preparation, review, track, manage, and submit regulatory documents required for study start-up at site level, and will maintain, review and report on site performance metrics

• Study Start-Up Planning: Collaborate with cross-functional teams to develop and implement study start-up plans for CNS clinical trials

• Managing and conducting start-up activities in compliance with the client’s procedures, documents, local and international guidelines such as ICH GCP and relevant regulations

• Work in close collaboration with the CRAs and the Study Team to ensure that study start-up activities and milestones are achieved in a timely and efficient manner

• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process

• 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

• Support QC checks performed by LSAD or delegate to ensure that all site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs

• 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 - 06/2018

• 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

• Working closely with CROs and other stakeholders to facilitate the timely initiation of clinical trials and ensure compliance with regulatory requirements

• Managing and conducting start-up activities in compliance with the client’s procedures, documents, local and international guidelines such as ICH GCP and relevant regulations

• Assists with completion of relevant Clinical Trial Management System 5 P a g e

(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 7 P a g e

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; Currently Attending

Contact this candidate