Patricia Curcio

Address: **** ******** *****, ***** ** 07470

Phone: 973-***-****

Email: adaeq2@r.postjobfree.com

Professional Experience

Aug 2015 - Present Syneos Health (Formerly inVentiv Health Clinical)/Home-based, USA

Line Manager/Sr. Project Specialist/ Data Entry Coordinator

Performs data entry into designated tracking systems in accordance with project

requirements, including collection of information from designated team members, CROs,or other vendors

Highly expereinced and skilled in Veeva TMF – seven years

Entered the 1572s, Regulatory Documents, Shipments Receipts and Drugs Receipts, Site information, Contract Information data into Excel Spreadsheets.

Guide Direct Reports on career path

Meet bi weekly with reports to discuss studies and tasks and issues

Approved timesheets every Friday

Ensure reports have allocation and assign new studies to those with availability

Ensure reports are completing trainings and are compliant

Interview new candidates for hire when needed

Provide (cross functional) clerical and administrative support to project team(s

Assist in the identification and recruiting activities for clinical trial investigators

Obtain, review, and process regulatory and administrative documents from investigator sites - Submit PI names for credentialing

Provides support to project team including, but not limited to, set-up, filing and maintenance of study file documentation, project tracking and information retrieval

Prepare and compile study related materials including investigator meeting binders, training manuals, and ISF

When allocated by study management, collection and preparation of essential/ required documents for submission to a central Institutional Review Board (IRB) or a country's central Ethics Committee, and if necessary based on local requirements the Competent Authority

Set up, maintain and review regulatory and administrative documents for the Trial Master File (TMF)

Responsible for quality checking the Trial Master File

Resolve issues, questions, and requests for additional study supplies

Responsible for completing minutes meetings and uploading them to the share drive

Responsible for running reports and forwarding to team members

Assist with the preparation and maintenance of study timelines, decision logs and status reports

Perform Rave quarterly reviews requesting submissions for deletion or updates

Review investigator files to ensure all documentation is complete and up-to-date

Train other Project Specialists on job functions

Apr 2012 - Aug 2015 Pharmanet/I3/ Home-based, USA

Sr. Technical Assistant, Clinical

Set-up and maintain project files and investigator files

Fax, photocopy, and distribute study-related documents

Contact study personnel at sites regarding (administrative) issues

Order and distribute office and study related supplies needed by project team

Generate, maintain and distribute study-specific reports (e.g. patient enrollment, regulatory documents, site visits, investigator payments)

Ship/mail supplies and documents to clients, investigator sites, and Institutional Review Boards (IRB)

Assist in assembling materials and binders for investigator meetings

Prepare regulatory binders (Study File Notebooks) for study sites

Maintain investigator payment documentation

When allocated by study management, collection and preparation of essential/ required documents for submission to a central IRB or a country's central Ethics Committee, and if necessary based on local requirements the Competent Authority

Set up, maintain and review regulatory and administrative documents for the Trial Master File

Mar 2009 - Apr 2012 Pharmanet/I3/ Office-based, USA

Technical Assistant, Clinical

See above Sr. Technical Assistant job description

Participated in doing projects in Medidata Rave

Jul 2007 - Mar 2009 Pharmanet/ Office-based, Blue Bell, PA

Administrative Assistant

Provide administrative support to multiple people/groups

Produce complex documents, correspondence and reports utilizing word processing, presentation and spreadsheet software including tables, listings and charts

Edit and proof documents according to high professional standards

Develop and maintain administrative systems to increase efficiency

Plan meetings, prepare meeting material and organize catering

Assist with providing timely and service oriented phone reception

Maintain calendar for senior management staff

Biography

Patricia Curcio has 9 years of experience in a Clinical Research Organization (CRO) as a Sr. Project Specialist/Project Specialist.

Patricia Curcio has one year of experience as a line manager with 4-6 direct reports at one time.

Patricia Curcio has one year of experience on the GRM Resourcing Team.

Patricia met bi-weekly 1:1 meetings with direct reports is to discuss project related questions, ensuring all direct reports are fully allocated and to provide guidance on the direct reports career path. Patricia provided support to each direct report including, but not limited to approving timesheets, answering questions, making sure each direct report is compliant with trainings. Patricia interviews new candidates for hire.

Patricia runs reports weekly for GRM Resourcing for the RWLP Department for allocations, availability and STAT weekly.

Patricia's primary responsibility as a project specialist is to keep the project and all related processes running smoothly. Patricia provides support to project teams including, but not limited to, set-up, filing and maintenance of study file documentation; project tracking and information retrieval; and assisting with maintaining metrics and timelines for various activities. A key task she is responsible for is performing accurate data entry into designated tracking systems in accordance with project requirements. To accomplish this, she is skilled in the following systems: Veeva, Medidata CTMS and RTII.

Patricia’s is highly skilled in TMF set-up, review and QC checks. Patricia is the first person requested when a study is in need of a QC. In addition, Patricia has supported several PM's and CRA Leads with the process of entering documents into an e-TMF system, as well as providing refresher trainings on how to QC documents.

Patricia has 9 years of experience in the Rheumatoid Arthritis therapeutic area within RWLP, and 5 years of experience in the Oncology therapeutic area. These include a registry study and an EAP study.

EDUCATION

1978 - 1982

Bachelor Degree of Early Childhood Education

Northeastern Bible College, Essex Fells, NJ 07021

ADDITIONAL

SKILLS

Microsoft Office package: Microsoft Word, Excel, Spreadsheets, Internet Explorer

System: iMedidata, Veeva, CTMS Siebel

REFERENCES

References available on request

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