Clinical Research Data Entry
Resume:
SUSAN ROSS TRUEHEART
**********@**.***
HIGHLIGHTS
**** – present: Clinical Research which includes Regulatory experience
Clinical Monitoring experience
Phase I, II, III, IV experience
TMF Specialist
CTA Specialist
THERAPEUTIC EXPERIENCE
Oncology
Neurology
Cardiology
HIV
CNS
PROFESSIONAL EXPERIENCE
7/2023 – Present Prevail InfoWorks
Project Coordinator
Maintain list of study and site contacts as required. Keep contact info up to date.
Manage system access
Assist with trial start up activities as required
Help with study plans/documents
Coordinate functional areas
Liaison with vendors for study deliverables
Assist in development, finalization, and approval of trial specific documents
Complete trial level templates
Attend meetings, take minutes, track attendance, provide metrics as requires, update and maintain action items
Support HA/EC submission activities, prepare submission documents as needed
Assist Safety group with site contact info as needed/verify their recipients list SUA/SUSARs, file any SUA reports
Distribute missing data reporting, assist in close out activities
Other responsibilities assigned by Director, Clinical Operations
3/2018 – 4/2023 Catalyst Clinical Research, Raleigh, NC
CTA/eTMF Specialist (long term contract)
Assist with data entry, proofing and distribution of project tracking reports that can include but is not limited to enrollment, monitoring visits, submission of trip reports and other study specific metrics.
Responsible for updating the Trial Master File (TMF) in accordance with Eisai file structure.
Perform quarterly audits on studies in the eTMF, maintain the filing for all studies, ensure all document are filed correctly in the eTMF
Responsible for routine maintenance of the TMF, including general filing and periodic auditing of files as directed by the Project Manager or Eisai Director.
Assist with the distribution and tracking of study supplies, including reference manuals and regulatory packets as well as study specific supplies as needed.
Responsible for the collection and tracking of regulatory documents using Eisai systems
Work with study team members to ensure that all study documents and files are accurate and current.
Coordinate and participate in team meeting; generate and distribute team meeting minutes.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow as assigned.
May serve as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Perform other duties as assigned which may entail supporting other Eisai studies/protocols
9/2017 – 2/2018 EmergeOrtho, Durham, NC
Patient Support Specialist
Greet and assist all patients and other visitors who arrive to EmergeOrtho.
Checks in patients for appointments, reviews and verifies demographics, confirming insurance eligibility, collecting all due balances, deposits and co-payments.
Provide patients with prescriptions, medical records and other needs as requested.
11/2016 – 4/2017 CMED Research, Durham, NC
Regulatory Specialist (Contract position)
Perform quality review of regulatory documents required for country approval In accordance with all applicable regulations, guidelines and Cmed procedures
Perform quality review and approval of regulatory documents required for site Initiation/drug release In accordance with all applicable regulations, guidelines and·Cmed procedures. These documents include, but are not limited to; required regulatory document packages, Informed consents, advertisements and patient related materials
Ensure that Regulatory Authority, Central and local EC submission timelines are met
Responsible for timely follow-up for Inquiries or objections made by RA/EC In collaboration with study team
Perform timely and accurate data entry of regulatory documents and maintenance of
country/investigator Information In the appropriate clinical trial management system
Perform regulatory document maintenance, amendments, periodic update and safety letters (safety reporting responsibilities In collaboration with the Drug Safety group)
Meet or exceed metrics for review and submission of completed RA/EC packets as defined by the
Regulatory Manager/Lead/Designee at study start
Meet or exceed metrics for error rate of completed RA/EC packets as defined by the Regulatory
Competent In communication skills for timely follow-up, Issue resolution and report updates; as outlined In the communication and escalation plan with timely documentation
Regulatory expertise and guidance
Attend study team meetings as required
Assemble and distribute study materials to clinical and project teams, Including materials to study sites and Investigator Meetings (e.g., Investigator binders) and vendors as appropriate
Responsible for compliance with applicable corporate and divisional policies and procedures
Broad knowledge of various technical alternatives and their potential Impact on the business
Coordinate Instructions for Use (IFU) and Informed Consent Form (IOF) development activities
Participate In department systems development Initiatives
Perform work without appreciable direction
Review completed work from a relatively from a relatively long-term perspective, for desired results
Assume additional responsibilities as directed by the Clinical and Regulatory Operations group
Support the Clinical and Regulatory Operations group with Improvement activities by providing Ideas, Implementation activities and adapting SOPs
Maintain confidentiality of management Information as appropriate
03/2015 – 09/2016 MedSource, Raleigh, NC
Regulatory Affairs Specialist
Assist with collecting, logging, filing, and/or tracking of study documents/trial master file in the project tracking system including site correspondence, vendor correspondence, IRB submissions and approvals, IND safety reports, case report forms (CRFs), regulatory and other study documents according to client/company Standard Operating Procedures (SOPs), ICH, and federal regulations
Assist with coordinating regulatory workflow, provide support to the regulatory team, and track regulatory project timelines
Receive and disseminate study-related regulatory documents and correspondence from assigned sites; screen documents for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of data
Assist in the production and distribution of various study-related, investigator, regulatory tools, and documentation (correspondence, operations, guidelines, training manuals, study forms, site regulatory binders, and worksheets)
Create and maintain tracking tools in support of project needs and in-house functions
Prepare reports from tracking tools to include weekly reports and other reports as requested
Communicate with sites to provide information, request updates, track documentation, and help to ensure the overall progress of clinical trials and adherence to established guidelines
Ensure that study materials and drug kits are shipped and re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to management as appropriate
Communicate regularly with study monitors as needed to resolve discrepancies and provide information before and after monitoring visits to participating sites
Communicate and coordinate with other study personnel including data entry and randomization personnel, pharmacy, laboratories, study sponsors, and others as needed for study implementation and routine problem resolution
Attend routine weekly meetings and other meetings related to assigned clinical trials and corporate projects; stay abreast of information and any changes to study protocol and project timelines
When specified, scan study-related documents and ensure that the quality of the electronic document is adequate, correct naming conventions are utilized, and verify the paper file matches the electronic file
Provide assistance with meetings (e.g., investigator, kick-off, team, etc.) and preparation of meeting agendas, minutes, and action items as needed
Prepare, proofread, and edit correspondence and other written materials (presentation, reports, etc.) as needed
Provide filing, faxing, photocopying, and mailing support for designated project
team(s) as required
12/2013 – 03/2015 GSK, Research Triangle Park, NC
Clinical Study Associate / Regulatory Specialist
Send CDA’s to 600 potential sites in order to select a total of 350
Send feasibility to sites as needed
Attending site selection meetings weekly and giving updates
Beginning discussions of the upcoming Investigators Meetings
Daily tracking of sites status
Sending site selection letters weekly
03/2013 – 09/2013 GSK, Research Triangle Park, NC
Study Manager
Set up and maintain ISS studies in the Lotus Notes Database
Perform bi-monthly file reviews
Maintain studies in eTrack
Contact study sites bi-monthly for study updates
Provide Monthly Budget Updates to the Finance Teams
Track and maintain the Publications database
Track milestone payments to sites
Perform quarterly milestone reconciliation
Fill out Proposal Summaries for new proposed studies, request contracts
07/2009 – 02/2013 Quintiles, Morrisville, NC
In-House Clinical Research Associate
Collect, track and review study site critical documents used to monitor interest for enrollment of investigative sites
Ensure compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti-Kickback Statute (USA) and the False Claims Act (USA)
Thoroughly document and track all communication (email, voice, fax, call reports) with all study site personnel and any client interaction in accordance with study plans
May assist in the development of site specific recruitment, retention and follow up plans / processes in line with the project strategy provided by Project Coordination Centre (PCC) Lead
Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans
Follow established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences
Evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection
Identify problems and/or inconsistencies; monitor site and subject progress, including documentation and reporting of adverse events; recommend corrective action as appropriate; escalate to PCC Lead or line manager as appropriate
Respond to questions on study procedures/protocol via the study hotline
Liaise and work in conjunction with CRAs monitoring on-site as needed
Perform on-site co-monitoring and remote monitoring activities as needed
Provide guidance to PCC Clinical Assistant staff as needed
04/2008 – 11/2008 Quintiles, Morrisville, NC
Associate Site Start-up Specialist
Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
Resolve site issues and report site status to SSU Team Lead.
Work with regulatory team members or sponsor to secure authorization of regulatory documents.
Work with legal team members or sponsor to secure authorization of contracts.
Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
Inform team members of completion of regulatory and contractual documents for individual sites.
Work with team members in preparation of regulatory submissions per work instructions.
May coordinate translation of critical documents.
May participate in feasibility and/or site identification activities.
01/2009 – 05/2009 Novella, Research Triangle Park, NC
Senior Regulatory Affairs Specialist
Support sponsor Study Management by providing study start up, maintenance and close-out activities for assigned studies
Gather, enter, interpret and apply information into various sponsor systems to support studies
Check own work and correct errors
Create and utilize customized reports develop basic information management solutions, participate in clinical team activities as assigned and contribute to deliverables
Participate in the development and implementation of key organizational process improvement initiatives
Work within standardized best practices
Ensure study related logistics are completed
When escalating complex requests, recognize underlying issues and communicate as appropriate
Participate in interviewing process of new hires as requested
Train and mentor entry-level or new staff as directed
Coordinate workflow, staff and tasks to accomplish study or project deliverables as requested
Set up and maintain method of tracking for study budget spend
Review and reconcile invoices/spend, and facilitate/coordinate investigator payments
Coordinate the preparation and the routing of clinical study agreements and ensure that fully executed agreements are in place prior to drug shipment and payment
Order, assemble, distribute, manage and track study conduct tools, and non-drug clinical supplies
Obtain, set up, and maintain sponsor study records according to FDA/ICH Guidelines and internal SOP’
Travel to sites and/or CRO’s to conduct file review, reconciliation and other closeout activities as requested
Collect, review and submit required documentation to TCS throughout the study
Liaise with meeting planning vendor in the logistical planning of study meetings (Investigator, CRO, Coordinator)
Assemble materials and travel to or attend meetings as needed
Contribute to content of Investigator Meetings and present at meetings as appropriate
Reconcile FIDS, CARDS and sponsor study records to provide documents to Records Management
04/1992 – 03/2008 GlaxoSmithKline, Research Triangle Park, NC
Clinical Study Associate
Routine administrative duties that included but not limited to study start up activities, maintenance, as well as close-out activities
Adhere to the GCP and ICH guidelines, FDA regulations and GSK SOPs
Participated in site recruitment activities that includes searching intranet for possible investigators to participate in the trial, present to team members at site selection meetings
Maintained investigator list on several required databases
Prepared and pre-populated regulatory documents for site mailings, received documents for review, submitted regulatory documents to regulatory for review as well as IRB
Assisted with travel arrangements and prepared expense report templates for investigator meeting
Attended investigator meetings, prepared power point slides, present regulatory document collection process as well as assist with travel reservations, dinner reservations and computer training set up
Budgets: prepared contracts, reviewed contracts and tracked accruals
Maintained database to track vendor payments, investigator payments and invoice processes. Communicated with external vendors regarding invoices
Tracked site information, regulatory documents and SAEs in several databases as well as on Excel spreadsheets
Attended study conduct meetings; prepared meeting minutes, stored minutes on shared area
Ran weekly reports of study progress that included regulatory status, patient data information, IRB submissions, and budget information
Activated drug shipments, tracked drug shipments, and collected drug accountability logs for files. Tracked patient visits to ensure timelines were met per protocol
Compared databases for correct data transfers of patient data
Worked close with data management on database comparisons, ran weekly reports and reported data at study conduct meetings
10/1988 – 04/1992 ClinTrials, Research Triangle Park, NC
Administrative Assistant
Secretarial support for statisticians, research support and department heads
Involved in typing final study reports, setting up tables for reports, logging in case report forms and assisted in quality assurance audits
Perform general secretarial duties for the monitoring department and assigned to different projects to type memos to investigators, take minutes at project specific meetings, perform mail merges, back-up secretarial support on the switchboard
GCP TRAINING
NIH: Protecting Human Research Participants, Jan2024
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