JESSIE T. SNEAD

*** ******** *****

CARY, NORTH CAROLINA 27518

919-***-**** (CELL)

acxvee@r.postjobfree.com

EMPLOYMENT OBJECTIVE:

Pursue career opportunities within the Government, Pharmaceutical, Contract Research Organization, Hospital or Biotech companies which allow the maximum use of my skills and abilities in a team oriented environment.

BUSINESS EXPERIENCE:

NC Temporary Solutions via Department of Human & Health Services

Project Assistant 9/16-10/16

Worked at DHHS in Certificate of Need department. Scanning documents to be sent to Institutions who wish to review their approved proposals for dialysis equipment to be placed in hospitals, dialysis centers, etc. Created letters requesting for information to finalized proposals. Copying and filing documents.

BioCryst Pharmaceuticals, Inc. via On Assignment Staffing Company

Clinical Trials Assistant 7/15 - 2/16

Assisted with managing internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective implementation of the Clinical Development Plan for one or more global development programs. Established and maintained effective communication and collaboration with functional area peers, including regulatory, quality assurance, project management, as well as clinical investigators in order to meet program objectives and support achievement of department and corporate goals. Implemented and maintained internal processes and systems to support the efficient and high quality conduct of clinical trials including clinical trial management systems (CTMS).

Quintiles North America, Inc., RTP, NC 9/10 – 5/15

Clinical Trial Assistant, Clinical Development Services

Assist Clinical Project Manager’s (CPM) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPS.

Assist with periodic review/audit of files for accuracy and completeness.

Assist with the coordination and tracking of all information, communications, documents, materials and supplies for assigned projects.

Assist with tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as Central contact for the clinical team for designated project communications, correspondence and associated documentation.

Support the coordination of project team and/or customer meetings including logistics and materials required.

Quintiles North America, Inc., RTP, NC 6/09 – 9/10

Research Coordinator, Clinical Development Services

Performed in-house monitoring service. Duties included managing the sites of various principal investigators remotely through interaction with assigned PI representatives and assisting with the development of Clinical management plans, Site management plans, and other related documents/agreements. Oversaw the collection of data from patient charts, medical records, interviews, questionnaires and AE/SAE reporting and ensure the accurate evaluation and quality assurance of collected data, and preparation of appropriate documentation. Ensured compliance with protocol guidelines and requirements of regulatory agencies and evaluated and interpreted collected clinical data in conjunction with the PI. Oversaw the site and patient reimbursement process and served as consultant on protocol and clinical research form (CRF) development as well as other study documents.

Quintiles North America, Inc., RTP, NC 2/04 – 6/09

Site Startup Specialist, Clinical Development Services

Reviewed and negotiated site regulatory documents, and contracts with sites and sponsors for agreement on wording and budgets. Maintained and managed Site Start Up data tracking entries in database. Reviewed for completeness and accuracy. Reviewed and provide feedback to management on site performance metrics. Served as contact for investigative sites, designated project reports, communications, and customer service. Resolved site issues and determine status for product shipment. Interacted with regulatory team members or sponsor to secure authorization of regulatory documents. Interacted with legal team members or sponsor to secure authorization of contracts. Interact 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. Worked with team members in preparation of Independent Ethics Committees and Institutional Review Board submissions per work instructions. Served as a Site Start Up Lead for project(s) as needed. Coordinated project-specific activities per work instructions with Site Start Up team.

The Copernicus Group IRB, Cary, NC 6/03 – 11/03

IRB Project Associate

Reviewed and processed New Principal Investigator Submissions for IRB Approvals. Contacted sites, sponsors or Clinical Research Organization’s in obtaining necessary follow-up information. Reviewed and processed significant protocol deviation reports. Researched PI medical licenses, analyzed Federal Drug Administration audit findings from 483’s and EIR Reports. Prepared documentation for Full Board Review and provided protocol tracking of document such as Waivers of Authorization and Investigator Site Questionnaires.Approved advertising of radio, TV and phone screening scripts; Recommended modifications to proposed scripts and ads. Prepared special requests for IC Translations; Paraphrase narratives for Serous Adverse Events, Protocol Deviations and Investigational New Drug safety reports for entry into the Access database. Attended Institutional Review Board Meetings.

GlaxoSmithKline, Inc. via The Woolf Group, RTP, NC 6/02-12/02

Contract Clinical Support Coordinator, Respiratory Clinical Operations

Supported Study Team Leaders, Non-Study Team Leaders, Scientists and Clinical Research Associate with study specific tasks. Supported clinical research activities including maintaining and auditing study files. Reviewed regulatory documents and submit for regulatory approval, and drug shipment process. Organized and maintained budget notebooks for several respiratory studies. Processed check requests, grant requests, invoices for clinical studies, laboratory assessments, consultants, etc. Tracked grant payments and invoices in ESD database. Provided Federal Drug Administration submissions process. Created indemnification letters, and confidentiality disclosure agreements. Filed IND safety reports in-house and generated to the Clinical Research Organizations. Created new investigators and sub-investigators record into MedTrack. Tracked enrollment in Ramos database. Updated and maintained FIDS database. Coordinated study conduct meetings. Participated in weekly teleconferences to communicate project status and updates to Contract Research Organization. Liaise with investigative sites, Contract Research Organization, and other groups within Glaxo SmithKline departments.

Ingenix Pharmaceutical Services (formerly Kern McNeill International), Cary, NC

Grants & Contracts Administrator 7/00-5/02

Negotiated budget agreements with Investigative sites and Site Management Organizations. Processed and submitted Clinical Study Agreements to prospective sites. Revised negotiated contracts and resubmitted to interested sites for execution. Acted as Liaison with sponsors on inquiries of clinical study agreements, and mailed copies of fully executed contracts on a weekly basis. Provided in-house support to directors, project managers, and Clinical Research Associates with grants and contract related issues. Responsible for creating and maintaining electronic budget tracking for investigator payments; such as, grant payments, advertising expenses, IRB expenses, procedural expenses, and contract forms. Organized and maintained contracts and budget files for all investigative sites. Prepared and processed check requests for grant payments, invoices for IRB expenses, advertising expenses, and clinical procedures. Submitted and tracked milestones for grant payments to overall listing of sponsors. Utilized ellipsis database to input updated information associated with the creation of payment modules. Responded to study related telephone inquiries from sites and screened calls as appropriate.

Kern McNeill International, Cary, NC 5/00-7/00

Administrator, Pharmaceutical Insourcing

Primary responsibility was to respond to candidate applications and arranged initial candidate interviews with Insourcing management. Maintained RAPID database, specifically entering new employee information and accessing records. Coordinated set-up for Regional employees’ home offices. Processed and tracked employees expense reports and clarify anomalies. Assisted with the compilation of client invoices. Created and maintained tracking magnetism with insourcing employee files. Coordinated the ACRP 2000 meeting (i.e. hotel and conference registration, booth shipping and return, give a ways and materials, convention orders, prepared and mailed ACRP 2000 invitation letters and promotion letters). Forward electronic copies of documents frequently used by the In-sourcing employees.

Kern McNeill International, Cary, NC 11/99-5/00

Coordinator, Regional Monitoring

Assistant to the Director of Regional Monitoring. Coordinated General Monitors’ Meetings, such as, involvement in agenda planning, scheduled meeting rooms and travel arrangements. Coordinated New Monitors’ Orientation in coordinating times, locations, presenters, scheduled meeting rooms, travel arrangements, distribution of agendas and assisted in presentation preparation. Created and maintained regional monitor database, which included demographic information, therapeutic experience, education of regional monitors, and site assignments, etc. Created and maintained employee files for regional monitors’ group. Liaison with the Finance department to expedite new hire forms, such as, American Express corporate card application, KMI American Express card application, and travel advance application. Liaison with IT services to ensure prompt home office set-up. Requested business cards for new hires. Forward electronic copies of documents frequently used by the regional monitors’ group. Distributed to the new hires the Site Monitors’ orientation handbook. Created and maintained the regional monitors’ directory. Maintained attendance records, and time off requests. Processed expense reports daily.

Glaxo Wellcome, Inc. via The Woolf Group RTP, NC 3/99-10/99

Contract Clinical Research Coordinator, Clinical Pharmacology

Organized and maintained budget notebooks. Processed check requests, grant requests, invoices for clinical studies, laboratory assessments, consultants, etc. Prepared and processed Clinical Research Agreements, Consultant Contracts, Service Contracts, and Central Lab Contracts. Requested indemnification letters for new studies. Set-up purchase requisitions, tracked and follow up. Set up, maintained and audit central files in compliance with Glaxo Wellcome Standard Operating Procedures and the Federal Drug Administration regulations. Maintained and updated study information in Medtrack and Medfinance. Liaison with investigative sites, Contract Research Organizations, and other groups within Glaxo Wellcome, such as, purchasing, Research & Development Finance, accounts payable, and Worldwide Medical Resourcing & Contracts.

Glaxo Wellcome, Inc. via The Woolf Group RTP, NC 8/97-3/99

Contract Clinical Research Coordinator, HIV/OI Clinical Development

Responsibilities included administrative and project coordination duties in support of Antiviral Clinical Research studies. Conducted word processing, distribution and routing of documents, investigator and project file maintenance in compliance with Glaxo Wellcome Standard Operating Procedures and Federal Drug Administration regulations. Assisted with budget processing (i.e. check requests, clinical trial payments) expense report processing and tracking. Coordinated complex travel arrangements, appointment/meeting scheduling, and telephone coverage. Met deadlines associated with New Drug Administration submission and project work. Performed assigned tasks in a timely and efficient manner. Assisted with regulatory submissions. Coordinated large meetings for section(s). Provided electronic Resource Tracking Finance for section.

EDUCATION

5/19 MOUNT OLIVE UNIVERSITY, Mt Olive, NC

Currently pursuing Associates & Bachelor’s degrees

6/93 ECPI COMPUTER COLLEGE, Raleigh, NC

Medical Computer Technology

7/82 WAKE TECHNICAL COMMUNITY COLLEGE, Raleigh, NC

Industrial Pharmaceutical Technology

SOCRA membership (2005-Present)

ICH/GCP Certified

NOTARY PUBLIC since 2009

SKILLS and ABILITIES:

Core Clinical Research Training Aug 2009, Phase I – IV studies, Organizational and office management skills, Microsoft Access, WordPerfect 5.1 and 6.0, Microsoft Excel 2007, Microsoft Office 2007, PowerPoint, Quattro Pro, Thecis and Orion, Lotus Notes, All-in-One, Russell Calendar, Clinical Programs Monitoring Systems, Ellipsis Network Systems, Oracle Clinical, BBN Network Systems, Macintosh, Medical Terminology, Medical Office Procedures, Medical Transcription, Editing Skills, excellent oral, written and communication skills. Clinical Administrative Processes & Procedures, Clinical Study Processes & Procedures, Medtrack, Medfinance, Managers Toolkit, Inntrax, Publishing, Clinical Informatics, CTMS, InForm and InFormant.

REFERENCES: Provided upon request.

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