Rose Allen-Bass

Gibsonville, NC *****

ad1f32@r.postjobfree.com 919-***-****

Ambitious Clinical Research Coordinator with several years setting up, supporting, and conducting clinical trials to determine safety and effectiveness of drugs, treatments, and medical devices.

Responsible and proficient in data management, protocol adherence while following good clinical practices. Passionate and motivated, with a drive for excellence.

Authorized to work in the US for any employer

Competencies/Technologies

Site initiations/study start-up

Military computer systems and application

to include AHLTA, CHCS, & Essentris,

Clinplus & IRBNet (software for clinical

EPIC (EMR System)

Athena net

RAVE EDC

ProSoft Clinical EDC

InForm EDC

Study Hub

eCOA

Microsoft Office Teams

ClinRo

Veeva

Electronic Data Capture

Team Center Database/Workflows

SharePoint

Electronic Medical Records

Microsoft Office (Excel,

PowerPoint, Word, Outlook)

eTMF – External Contribute User

Reveal

OPTUM PRO Insight

(Smart Measurement System)

Clintrix Workspace

Twilio Flex Communication System

Cisco IP Communication System

Work Experience

Global Medical Information Operations Specialist

Mindlance / Otsuka Pharma – Remote August 2022 to Present

Provides operational/administrative support to the Global Medical Information Department

Handles all medical information inquiry case creation, case entry, and case updates

Responsible for the loading of all medical information content & administration of all content folders within the content management system (IRMS)

Manages all medical information global email boxes, and monitors/handles/escalates incoming emails accordingly

Handles adverse event reporting reconciliation processes for the department

Assists with non-product case management entry & fulfillment as needed

Handles various administrative functions for the department such as reports, metrics, mailing/fax requests, expiry changes, QA review, SharePoint/folder management, etc.

Manages literature database searches, article fulfillment requests and article ordering in compliance with all copyright laws & procedures

Virtual Study Concierge /Study Assistant

Cynet Health / IQVIA - Remote July 2021 to July 2022

Provide clinical research support to the virtual investigators and their study staff to prepare for and execute assigned research studies,

Patient Communication (Finesse, Omni chat, Patient Training, Data surveillance, patient follow-up, Training of Sites (i.e., Onboarding), call center

Communicate with Sites on timelines for deliveries/collections and requirements as documented in the protocol and agreements.

Project planning, set up and administrative activities, meetings, and data Entry,

Prepare and disseminate study-related documents and materials to sites

System Support, (i.e., Study Hub, Clinical Ink), any other 3rd party vendor system required for virtual trials

Attend all relevant study meetings and trainings

Support other job-related duties as assigned by the Clinical Lead or designee.

Clinical Research Specialist, Sr.

Grace Federal Solutions, LLC / Duke Cancer Institute - Durham, NC

February 2021 to May 2021

Performed a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Cancer Institute’s Bone Marrow Transplant, Haematology Malignancies and Cellular Therapy Clinical Research Program.

Participated in day-to-day related to collection, compilation, and documentation of clinical research data through patient chart review

Utilized Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study trial data.

Study Coordinator

St. Vincent's Spine & Brain Institute - Jacksonville, FL February 2017 to August 2020

Collects and analyzes clinical data from multiple sources for the development of reports and statistical information

Review information for accuracy and reconciles data on a regular basis

Consent patients for new device studies

Data Entry of CRF (Clinical Research Form) into EDC system and maintains Excel data spreadsheets

Maintains ongoing study-specific clinical trial tracking documents

Abstracts patient information from EMR (Athena)

Clinical Trials Assistant l

Clinical Solutions Group - Quintiles/IM - Durham, NC September 2016 to February 2017

Assisted Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA), Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures (SOPs).

Assisted with periodic review of study files for completeness.

Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

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

Regulatory Document Specialist

Unified Women's Clinical Research - Winston-Salem, NC February 2016 to July 2016

Established and maintained a document management system for regulatory paper and electronic files.

Reviewed all Investigator Site regulatory documentation to ensure compliance.

Maintained proper communication with Sites to ensure regulatory compliance.

Organized and maintained FDA, IRB and GCP required regulatory documentation for individual sites and studies.

Maintained ongoing study-specific clinical trial tracking documents and distributed as needed.

Clinical Research Coordinator II

Kelly Services - Durham, NC November 2015 to January 2016

Provided support to the Ventricular Assist Device Program and other Divisions within the Department of Surgery

Met increasing data collection and regulatory demands of current studies and upcoming clinical trials

Ensured compliance with protocol and guidelines were applied when reporting adverse events

Met the increasing data collection and regulatory demands of current studies and upcoming trials, based on the volume of enrollment within the L Ventricular Assist Device Program.

Resolved and closed all outstanding data queries issued by safety

Research Regulatory Specialist

St. Vincent's HealthCare Inc - Jacksonville, FL May 2015 to October 2015

Coordinated, prepared, reviewed, and submitted regulatory documentation to Intuitional Review Board

Reviewed and recommended changes to departmental policies, procedures and standards to commensurate with regulatory developments

Reviewed and researched pertinent trends, issues, and developments in research, disseminated information to staff, and maintained regulatory references and materials

Collaborated with management of regulatory-related issues including serious adverse events and human subject participation

Regulatory Document Specialist I - InVentiv Health Clinical

J&J/Vistakon Inc - Jacksonville, FL July 2014 to January 2015

Uploaded metadata, propagations, and Document revisions into Document Management System

Edited and prepared new/revised documents and forms that were submitted for the documentation processes and ensured compliance for regulatory standards

Utilized computer networks to transfer approved (and effective) documents to the on-line system; maintained and supported on-line files, and signatory matrices

Handled other documentation-related duties within the department including auditing dossiers for submissions, registration, and licenses for other countries

Working knowledge of PMA (510K), EU (European Union) Medical Device Regulations

Clinical Research Coordinator - General Dynamics Information Technology

Naval Hospital

February 2012 to July 2014

Coordinated and facilitated research activities of assigned Institutional Review Board (IRB) approved study protocols using communication, and leadership skills for complex research protocols involving human subjects.

Performed duties of Associate Investigator

Research Activities: screened, recruited, and enrolled study participants, execution of study protocol by obtaining informed consents, data collection, management for generation and finalization of CRFs),

Interviewed and educated participants study compliance, follow-up activities, (i.e., phone calls and/or correspondence)

Reported and documented adverse events to governing agencies and sponsors as required by protocol and regulations

Data Documentation Specialist

Kelly Services - Morrisville, NC February 2010 to February 2012

Performed data entry from paper format into computer application

Measured, sorted, interfiled, and filed batched documents

Performed audits and quality control checks on data keyed by another staff members

Clinical Support Associate

InVentiv Clinical, LLC/GlaxoSmithKline - King of Prussia, PA June 2008 to December 2009

Administrative duties related to site initiation/study start-up to include completion of regulatory requirements/documentation, credentials verification of physicians, nurses, and study support personnel

Conducted training and served as help-desk support for study staff completing required study/IRB training

Management of Confidential Disclosure Agreements

Pre-screened new study Investigators and Sub-Investigators for new studies

Ran Master User List reports

Education

M.A. in Human Service Counseling/Criminal Justice

Liberty University - Lynchburg, VA August 2019

B.S. in Interdisciplinary Studies

Liberty University - Lynchburg, VA May 2013

A.A.S. in Business Administration Piedmont Community College - Roxboro, NC May 2010

A.A.S. in Medical Office Administration

Piedmont Community College - Roxboro, NC May 2008

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