Address: **** ******** *****, ***** ** 07470
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
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
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.
1978 - 1982
Bachelor Degree of Early Childhood Education
Northeastern Bible College, Essex Fells, NJ 07021
Microsoft Office package: Microsoft Word, Excel, Spreadsheets, Internet Explorer
System: iMedidata, Veeva, CTMS Siebel
References available on request