DENISE Du PREE’, LPN

Whispering Pines, NC

actcr9@r.postjobfree.com

919-***-****

OBJECTIVE: To obtain a challenging position that will allow for use of current knowledge, skills and

abilities toward attainment of career goals.

SKILLS: Nursing Clinical Trials Supervisory/Training Regulatory Filing/Reporting Paralegal 10 yrs

SOP GCP/ICH Guidelines Contracts/Budgets Site Identification QA Pharmacovigilance

SSU Medical/Scientific Concepts Clinical Trial Phases 1-4 CRO EDC FDA CAPA

CDA’s Contracts View Pier IMS Clinical Data Browser Grant Plan Data/Report Tracking

21 CRF Part 11, Clinical Operations, Drug Development Clinical Data Management Protocol

CERTIFICATIONS: CTMS / ICH Good Clinical Practice / Collecting and Reporting Adverse Events in Research

Trial Master File (TMF) Certified, Pharmacovigilance, Argus

Basic Life Support AHA

Wake Technical Community College – Medical Assisting Advisory Board Member

EDUCATION: Licensed Practical Nurse - Multi-State License

Wake Technical Community College – RN (In progress)

Preceptorship: Wake Medical Trauma Hospital/Rehabilitation Center

Whitehall Training- Pharmacovigilance (Drug Safety, Global Regulatory Req, AE, Argus)

Accomplishments: Dean’s List, Preceptorship: Training w/Nurse Mgr (16 weeks - 8 Patients), Perfect Attendance

PROFESSIONAL EXPERIENCE:

04/14 - GlaxoSmithKline/inVentiv Health

Contract Manager (Remote)

* Supervise, Train, Mentor and Manage work of Junior Analysts

* Maintain Negotiation (language/budget) of multiple studies of investigational drugs (Early and Late [Phase 1-IV])

* TA: CV Metabolic, Infectious Disease, Immuo-Inflammation, Neurology, Oncology, Respiratory

* Draft and negotiate minor contractual language/terms governing the testing of investigational drugs

* Gather and QC information received from study team and investigational site for protocol compliance

* Escalate errors and draft report of any inaccurate findings to study team Managers

* Point of contact/liaison between Investigators, Sites and Sponsor (GSK/inVentiv Health)

* Interfaced with site CRA/Monitor regularly regarding site compliance and execution Regulatory/Study documents

* Report any misrepresentation to Investigator/Site contacts and any failure to comply with SOP’s

or lack of transparency

* Interact with interrelated departments as a whole such as legal, regulatory, ICG, R&D, Grant Plan, etc.

* Worked closely w/Monitor to initiates site activation, drug delivery and submittal of invoices for site payment

* Reviews customer contracts to determine contract obligations and prepare necessary documentation

* Serves as a resource for contract related issues for both internal and external clients

* Provide guidance and contractual expertise to the client services, legal and business units

* Adhere to internal and external study deadlines

* Monitoring and staying abreast of applicable laws to maintain continued compliance

* Issue escalation of any incorrectly coded billing issues or lack of payment, etc.

* Site Management using Clinical Data Browser

* Stay abreast of GCP and ICH guidelines as well as global drug safety and clinical trial regulations

* Ensure all documents are properly saved in Contracts View and Pier for auditory purposes

* Work within projected internal/external timelines

01/14-10/2015 UniHealth/Pruitt Health ( PT – Volunteer/unpaid work)

Licensed Practical Nurse – Home Care Nurse

* Provide nursing care to patients in home and care setting, encompassing a range of medical procedures

* Monitor patient status, compliance and performance of procedures

* Administer medications and treatments, check vitals daily, assist with ADL’s

* Report any abnormal findings or concerns to Charge nurse/Doctor

* Assist patients with medication and pain management, edema control, wound care, ROM, etc.

* Evaluate patient /family needs in the preparation and executions of the interdisciplinary plan of care

* Teach patients and caregivers procedures and compliance in preparation for discharge from service

07/12 -01/14 LPN Nursing Student (FT) – Wake Technical Community College – Raleigh, NC

* Practical Nurse Clinical Training - Wake Medical Trauma Hospital (12 hour/weekend shifts)

* Head to toe nursing care; treatments, wound care, medication management, patient teaching,

admittance, discharge instructions

04/12–01/13 Quintiles/Randstad Pharma (Contractor)

Site Identification Specialist (Remote)

* Managed /coordinated independent activities associated with site identification for complex projects

* Point of contact between site contacts, investigators and CRO; Respond to site questions/concerns

* Participated in weekly Investigator and internal team meeting for startup/study initiation

* Interact daily with Feasibility, Medical Scientific Services and Clinical Operations

* Identify/qualify investigators to ensure their site attained sufficient patient population to participate in trial

* Reviewed and tiered sites according to historical site performance and relative criteria

* Entered new sites and investigators into performance database, submit PI’s for QA review

* Tracked all project activities in Quintiles database systems as applicable

* Track and QC’d Confidential Disclosure Agreements (CDA’s) and Site Information Forms (SIF’s)

* Track and review site capability, availability and status via CTMS

* Provide project progress reports to internal project teams and maintained departmental files

01/11-04/12 Cleaning Works

Office Manager/Contract Negotiator

* Negotiated business and service contracts

* Marketing, Accounts Payable/Receivable

03/07–01/11 GlaxoSmithKline (Contractor)

Clinical Trial Specialist (Remote)

* Managed 10-12 active studies concurrently (Phases 1-IV)

* TA: Oncology, Respiratory, CV Metabolic, Infectious Disease, Immuo-Inflammation, Neurology,

* Draft, send and receive executed Clinical Study Agreements (“CSA’s”) and Per Patient budgets

* Assist Study Start-up teams with the preparation/drafting of initial contract language

* Create/maintain site list and contract tracker and internal data base files

* Perform high quality (QC) of clinical review of regulatory forms and study related documents

* Participated in conference calls with site contacts, study management team, project manager and other

internal/external components as necessary

* Managed contract/budget until fully executed and received in-house

* Interacted regularly with the study management team, project manager, CRA’s daily, etc.

* Multiple therapy areas: neurology, oncology, respiratory, cardiology, infectious diseases

* Submit Site/study related invoices for payment

* Worked within projected internal/external timelines

References Available Upon Request

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