Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017

*** ******** ***, ****. * Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 1

Sr. Clinical Trial Associate (CTA)

Education

Colorado Technical University

o Associates of Science Health Administration Services – Highest Honors (2014) Colorado Technical University

o Bachelors of Science Healthcare Management – Magna Cum Laude (2016) Summary

• Clinical Research Therapeutic Areas include:

o Neuroscience

o Immunology

o Oncology

o Healthy Patient Volunteer

• Professional Skills:

o EKG Technician/Phlebotomist

• Experience in Electronic Data Capture trials:

o Siebel Clinical Trial Management System (sCTMS)

o Electronic Trial Master File (eTMF)

o Clinical Trial Safety Reporting System (CTSRS)

o Intralinks (ILP) and CTSRS

o eRoom

o Veeva Vault (vTMF)

o iMedidata (mCTMS)

o Study Central (CRO System)

• Training:

o Standard SOP Trainings for role/organization (via current employer) o Good Clinical Practice (GCP)

o Good Documentation Practice (GDP)

• Key Skills:

Agora Reporting, Ariba, Beacon, Greats (Records Management), FlexPlace, International Contract Database (eICD), PharmaDoc Viewer, Tru Vault, iGuide, Microsoft Office Suite (MS Access, MS Excel, MS Outlook, MS PowerPoint, MS Publisher, MS SharePoint, MS Visio, MS Word), Adobe Professional, Net Suite CRM, various proprietary software systems. Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 2

Professional Experience

Advaxis, Inc. Princeton, NJ

Sr. Clinical Trial Associate

Sept 2016 - Present

• Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA regulatory requirements as well as ICH/GCP guidelines

• Assist in the management of clinical projects that may be either local (single country) regional (i.e. North America) and global in scope, when internally or externally sourced

• Demonstrate an awareness of FDA and global health authority regulations and guidelines

• Assist with activities, which support trial management deliverables across the various phases of a trial (start-up, execution and close-out) as assigned by the Functional Manager

• Assist with setting up meetings, facilitating and maintaining minutes/documentation with the respective Project Manager

• Support management of the TMF (Central Administrative File) with the respective Project Manager

• Manage applicable systems with expectations that study status is available at all times; work with Study Manager(s) to ensure trial specific data are up-to-date, complete, accurate and consistent

• Support team-specific SharePoint sites, folders, and documents to ensure availability of all central trial documents

• Liaise with Contract Research Organization/Academic Research Organization as defined by Study Manager.

• Other duties as assigned:

o Collect and track patient enrollment information across all trials and update management on a bi-weekly basis

o Track the trial related information on a trial master spreadsheet: trial team members: sponsor, CRO,

partners, vendors; investigators; timeframe when

regulatory documents are sent to internal regulatory department for FDA submission; regulatory package

review; insurance policies per country; -80 freezer shipments/issues; patient ID bracelet(s)/translation(s); site supplies (laminated cards). This document will continue to evolve with the trial

• Taking meeting minute(s) for internal team meetings Study Assignments

Ongoing Drug Indication / Therapeutic Category

Cervical Cancer

(Subjects With High Risk Locally Advanced Cervical Cancer) Responsibilities:

• Countries handled: 20+

• Number of Sites: 150+

• Study Phase: 3

Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 3

Enrollment Estimate: 450 subjects

DOCS Global Home-Based

Sr. Clinical Trial Assistant

Sept 2014 to Sept 2016

• Focus primarily on complex and/or multi-country trials, but may also support small multi-country studies or local activities for larger multi-country studies

• Objective is to ensure maximum success of conducted protocols through clear communication and collaboration between all four roles: CTA, LTM, SM, GTM

• Responsible for the collection, review, and maintenance of site specific (IF) regulatory documents (as well as assist with LAF/CAF documents)

• Manage logistical and administrative tasks related to the entire life of the study, which include pre-trial activities, trial start-up, and trial conduct/execution and close out of clinical trials

• Perform the technical regulatory document review, including Informed Consent Forms

• Ensure trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements.

• Contribute to process improvement, training and mentoring of other CTAs

Specific Job Responsibilities

Pre-Study/Feasibility

• CDA & Feasibility Distribution to potential sites.

• Ensure timely completion of site feasibility questionnaires for investigators being considered for study participation

• Conducts Feasibility checks of potential investigators against exclusion databases and alerts LTM of any findings

• Confidential Disclosure Agreement negotiation and finalization with potential sites

• Upon site selection create sites in CTMS System & VTMF

• Complete expected IRB submission dates in CTMS System

• Initiate and Maintain potential and selected site information in the Trial Master Spreadsheet

Study Start Up

• Distribute, collect, review and track regulatory documents, agreements and training documentation

• Shipment of paper TCF Binder and Site IP Binder Mailings

• Conduct start-up database checks for selected sites against exclusion databases and check IEC/IRB registrations and alerts TM of any deviations

• Track findings in Trial Master Spreadsheet (TMS)

• Initial Financial Disclosure Form collection, filing and tracking

• Conduct Initial EDL Setting meeting (vTMF)

• Provide Transmittal and Summary form (initial submission) to Regulatory

• Enter Site contacts and safety report contacts in CTMS System

Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 4

• Trigger safety report distribution in CTMS System via SUA tick box

• Review site specific Informed Consent Forms (ICF) for completeness and secures approval of changes to mandated language in collaboration with LTM, CGA, Legal department, etc.

• Ensure ICF review is complete in time for individual site IRB submission deadlines

• Assist with Site IP Approval process for Drug Shipment and Site Initiation

• Assist with creation of Filing and Archiving Plan, SIV Q&A

• Document and Annual Quality Review Forms (as applicable)

• VTMF, CTMS System timely system updates. Study

• advertisement review (if applicable)

• Maintain Document trackers – Trial Master Spreadsheet

(TMS), CTMS System FDF Trackers, ensure ICF Tracking Spreadsheet is kept up to date

• Complete the Expected and Actual IEC/IRB Approval dates in

• CTMS System

• Maintain Paper files and keep V-TMF current

Conduct & Closure

• Continued trial document collection

• Process Protocol Amendments, IB Updates, Revised ICFs as per the timelines required by study teams

• Collects and tracks Financial Disclosure information at appropriate time points (End of Study/Interim and One Year Post timepoints)

• Maintain paper and electronic investigator files

• CTMS System and VTMF updates

• Update Transmittal and Summary Sheet with Updated VTMF numbers

• Ensure all reconciliation time point observations answered and resolved within 4 weeks of receipt

• Re-check M.D.s and D.O.s in exclusion databases

periodically for longer studies

• Audit and Reconcile Site files on a regular basis to ensure compliance throughout life of trial Support site closure per required timeline; all IFs to be complete, reconciled and closed, files ready for archiving by 3 months after study closure (or per timeline as agreed upon with LTM/FM)

• Add One Year Post IFDF collection date to Centralized spreadsheet

• No delay of site CLOSED in CTMS System for controllable CTA-related activities

• Regulatory files are fully reconciled within twelve weeks after Last Subject Last Visit

• Initiate study close form to safety department

Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 5

• Complete List of Investigators and List of IRBs so that they can be included in the Clinical Study Report that the Sponsor company submits to the FDA

• Coordinate paper site file archival with designated individual Reconciliation and Quality Review

• Ensure the Quality & Content of Investigator Files and provide documentation of file oversight & maintenance

• Ensure Site Investigator Files are reconciled at the following time points:

o Within 6 weeks of IP sign-off

o 3 Months (if applicable)

o 6 months (and every 3 months until study close)

o Pre-COV

o Final Reconciliation

o Pre-Audit Reviews (as needed)

o Track all documents in the Reconciliation

Spreadsheet and all observations addresses within 4 weeks

Study Assignments

Trial Completed Drug Indication / Therapeutic Category Healthy Male Subjects (Spray-Dried Powder Tablet Formulation) / Oncology

Responsibilities:

• Countries handled: USA

• Number of Sites: 1

• Study Phase: 1

Study Assignments

Trial Completed Drug Indication / Therapeutic Category Insomnia Disorder without Psychiatric Comorbidity / Neuroscience Responsibilities:

• Countries handled: USA

• Number of Sites: 1

• Study Phase: 2a

Study Assignments

Trial Completed Drug Indication / Therapeutic Category Social Anxiety Disorder / Neuroscience

Responsibilities:

• Countries handled: USA

• Number of Sites: 9

• Study Phase: 2a

Study Assignments

Trial Completed Drug Indication / Therapeutic Category Major Depressive Disorder with Anxious Distress / Neuroscience Responsibilities:

• Countries handled: USA

• Number of Sites: 8

• Study Phase: 2a

Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 6

Study Assignments

Trial Completed Drug Indication / Therapeutic Category Autism Spectrum Disorder / Neuroscience

Responsibilities:

• Countries handled: USA

• Number of Sites: 9

• Study Phase: 0

May 2015 to Mar 2016 Site Staff Training Process/Documentation (ST3) Provide Technical Support for the Site Staff Training Process to ED&CP (workload divided among several technical support staff). Provide support to other Technical Support Staff as needed. Technical Support for the Site Staff Training Process entails the following responsibilities:

INITIAL SET UP

• Meet with GTM to review the process, review the GTM responsibilities and provide instructions on completion of the GTM Worksheet (define required tasks and associated required trainings for the protocol)

• Create the ST3 based on completed GTM Worksheet and any additional input from the GTM (training materials should be reviewed whenever possible to ensure the information provided by the GTM is consistent with the actual training materials)

• Create the SSL-DoR based on the finalized task list from the ST3

• Create the ISTD/ISTD ED&CP based on the finalized training list from the ST3 (and note all training material version dates) training list to the ITSD/ISTD ED&CP and/or any specific access information needed by the site staff

• If required for the trial, create Study Training Manual based on materials provided by GTM

• File finalized study-customized forms to V-TMF

• Provided final study-customized forms to GTM to cascade to LTMs/SMs/IDMs

WHEN UPDATES ARE NEEDED:

• Review with GTM any required changes (determine with the GTM if re-training is necessary for any previously trained site staff when implementing revisions/changes to existing training materials)

• Analyze the impact on existing site level forms to ensure implementation does not compromise the integrity of existing information

• Obtain updated training materials from the GTM

• When changes are required, update the study-customized ST3, ISTD/ISTD ED&CP, SSL-DoR and/or Study Training Manual based on the nature of the changes required (the Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

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TDattilo_29-Apr-2017 7

update would be made to the “master” study-customized forms)

• Maintain version history when updates to study-customized forms are required

• In the case of changes to the ST3, after changes to the Master study-customized form is finalized then “apply” that change to the existing ST3s for each individual site

(Carefully log the changes made to existing site-level documents)

• When an update is required, final revised study-customized forms are posted to V-TMF and provided to the GTM for distribution to the team/sites. Provide detailed

implementation instructions to the GTM to ensure the LTMs/SMs/IDMs are aware of their responsibilities and how the revised documents are to be implemented at a site level.

Kelly Services, Inc. Spring House, PA

Administrative/Project Support

(Performing services on behalf of

Janssen R&D GCO TCSM, placed on-

site at client)

Aug 2013 to Sept 2014

Supported – Director (DIR), Associate Directors (Assoc Dir), Functional Managers (FM), Local Trial Managers (LTM), Clinical Research Specialist (CRS), Clinical Research Associate (CRA), Site Managers (SM)

• Study-Start up processes, i.e. letters (site selected for PSV, site selected for study participation, site not-selected), preparing/shipping Study Related Documentation and Materials to Clinical Sites (Investigational Product Procedure Binder, Subject Emergency Wallet Cards, IVRS Envelopes

• Communicate(s) with sites on document updates,

corrections, and upcoming events (i.e. investigator meetings, site profile forms, newsletters, study updates)

• Study Closure: Drug Reconciliation, Collection of Financial Disclosure Forms

• Collection of site training documentation from clinical sites via the SM and filing within the study on SharePoint (Site Signature Logs, Trial Center Visit Log, Site Staff Delegation

& Training Log)

• IRB Study Portal document comparison to eTMF

• Pulling Serious Adverse Events (SAEs) from Clinical Trial Safety Reporting System (CTSRS) and mailing to appropriate sites

• Monitoring electronic mailboxes for Serious Adverse Events

(SAEs) Suspected Unexpected Serious and Associated Adverse Reactions (SUSARs/SUAs), and forwarding to the appropriate Local Trial Manager/Team for processing

• Running departmental reports

• Inputting/Updating Clinical Trial Management System

(CTMS)

• Managing uploading of documents to Study Site in the Electronic Trial Master File (eTMF)

Toniann Dattilo *Relocating from NJ to Clarkston, GA by mid-September 2017 616 Sturwood Way, Bldg. 6 Lawrenceville, NJ 08648

732-***-**** ac0c1q@r.postjobfree.com

TDattilo_29-Apr-2017 8

• Created a SharePoint site to coordinate most requests; i.e. filing, mailings, study inventory

• Process internal/external Purchase orders; i.e. office supplies; meeting handouts (i.e. posters, booklets, giveaways)

• Coordination of study archival and off-site study storage/retrieval based on the SOP for GREATS Archiving Kelly Services, Inc. Horsham, PA/Spring House, PA

Administrative/Project Support

(Performing services on behalf of

Janssen R&D, placed on-site at client)

Feb 2011 to Feb 2013

Supported – Director (DIR), Associate Directors (Assoc Dir), Functional Managers (FM), Local Trial Managers (LTM), Clinical Research Specialist (CRS), Clinical Research Associate (CRA), Site Managers (SM)

• Study-Start up processes, i.e. letters (site selected for PSV, site selected for study participation, site not-selected), preparing/shipping Study Related Documentation and Materials to Clinical Sites (Investigational Product Procedure Binder, Subject Emergency Wallet Cards, IVRS Envelopes

• Communicate(s) with sites on document updates,

corrections, and upcoming events (i.e. investigator meetings, site profile forms, newsletters, study updates)

• Study Closure: Drug Reconciliation, Collection of Financial Disclosure Forms

• Collection of site training documentation from clinical sites via the SM and filing within the study on SharePoint (Site Signature Logs, Trial Center Visit Log, Site Staff Delegation & Training Log)

• IRB Study Portal document comparison to eTMF

• Pulling Serious Adverse Events (SAEs) from Clinical Trial Safety Reporting System (CTSRS) and mailing to appropriate sites

• Monitoring electronic mailboxes for Serious Adverse Events

(SAEs) Suspected Unexpected Serious and Associated Adverse Reactions (SUSARs/SUAs), and forwarding to the appropriate Local Trial Manager/Team for processing

• Running departmental reports

• Inputting/Updating Clinical Trial Management System

(CTMS)

• Managing uploading of documents to Study Site in the Electronic Trial Master File (eTMF)

• Created a SharePoint site to coordinate most requests; i.e. filing, mailings, study inventory

• Process internal/external Purchase orders; i.e. office supplies; meeting handouts (i.e. posters, booklets, giveaways)

• Coordination of study archival and off-site study storage/retrieval based on the SOP for GREATS Archiving

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