Denise M. Darnell, RN, BSN
5382 Josephine LN SW
Concord, NC 28207
 [Send email to request phone number] 55-9750 (Home)
 [Send email to request phone number] 98-9247 (Cell)
E-mail: 

Professional Experience

PharmaNet, RTP and Charlotte, NC 11/2002   “ 11/2008

Manager, Clinical Research (07/2006   “ 11/2008)
    Manage interdisciplinary clinical research projects, as Project Manager,
leading the clinical team to ensure on-time, on-budget performance
    Supervise, train, and mentor Clinical Research staff
    Approve investigator study budgets and contracts
    Review and approve regulatory and administrative documents from investigator
sites
    Review and develop protocols and Case Report Forms (CRFs)
    Plan, coordinate, and present at Investigators  ' Meetings
    Review Serious Adverse Event (SAE) reports
    Review and approve monthly client invoices
    Prepare project management reports for clients, project personnel and 
 management
    Review and approve monitoring trip reports
    Review Tables and Listings generated from study data
    Author Clinical Study Reports
    Train CRAs on monitoring, internal procedures, and query resolution
    Mentor Senior CRAs on project management procedures and policies

Senior Clinical Research Associate (07/2004   “ 07/2006)
    Monitored Investigator sites
    Tracked and maintained budgets, timelines, and project tasks
    Organized and presented at Investigators  ' meetings
    Led team meeting with sponsor
    Developed protocols and CRFs
    Provided training to other clinical research personnel
    Prepared status reports for clients and PharmaNet management
    Negotiated budgets prepare contracts and make payments to study sites

Clinical Research Associate II (11/2002   “ 07/2004)
    Conducted pre-study, initiation, routine monitoring and close-out visits
    Recruited Investigators
    Processed regulatory and Investigator documentation
    Developed protocols, CRFs and monitoring conventions
    Presented at Investigators  ' meetings
    Prepared status reports for clients and PharmaNet management
    Reviewed CRFs and other study data in-house
    Negotiated budgets, prepared contracts and made payments to study sites
    Provided training to other clinical research personnel

Project Experience

Phase

Indication and Drug Class

Description of Responsibilities/Tasks
III fibrin sealant   “ used to
decrease amount of bleeding
on sternal incisions
 Recruit Investigators; CRF development;
regulatory document collection; file
maintenance; develop presentations, present
at Investigator meetings; assist in protocol
development
II atherosclerosis in coronary
artery disease subjects   “
Acyl-CoA: cholesterol
acyltransferase (ACAT)
inhibitor Routine monitoring; discontinue subject listing maintenance; Data
Collection Form (DCF) and SAE reconciliation. Project management from
Study maintenance through data base lock.
III erectile dysfunction Reviewed trip reports and performed co-monitoring
visits
III ocular anesthesia Project management including study start-up activities
through close-out visits. Organized the writing of the clinical study report and
the
FDA submission of an ANDA.

I/II/III pediatric vaccine Project management including study start-up,
staffing, CRF design, CRA training, assisted in design of Pharmanet computerized
tracking tools.
II/III Diabetes; Gastroenterology;
Pediatric dermatitis & otitis
externa; Anticoagulation
therapy
 Protocol management including protocol
writing, study design and staffing. Also
involved in the proposal process including study budgets and site budgets.

PPD Development, Morrisville, NC 06/2001   “ 10/2002

Clinical Research Associate
Therapeutic areas   “ neurology, sepsis, cardiovascular, diabetes
    Participated in the conduct of multi-center clinical research studies
    Reviewed project related materials and literature to develop a basic
understanding of the protocol and therapeutic areas
    Participated and presented at Investigator meetings for assigned studies
    Assisted in Investigator recruitment
    Evaluated, initiated, monitored, and closed out sites according to
applicable SOPs and FDA guidelines
    Reviewed CRFs for completeness, clarity, legibility, conformity to available
source documentation, and adherence to protocol requirements
    Resolved CRF discrepancies and clarifications via site visit, telephone, or
fax as
deemed appropriate for the study
    Performed drug accountability, ensured reporting of adverse events, and
verified completeness of critical documents

 Carolinas Medical Center, Charlotte, NC 05/1985   “ 05/2000

Research Coordinator, Clinical Trials Office (04/1996   “ 05/2000)
Therapeutic areas   “ adult and pediatric HIV, neurology, pediatrics, trauma,
orthopedics, male baldness, diabetes
    Served as study coordinator in multi-center drug and device trials
    Implemented protocols according to ICH-GCP, and Federal regulations
    Conducted pre-initiation, initiation, ongoing periodic and closeout visits
with the CRO and sponsor
    Performed Institutional Review Board (IRB) preparation for initial approval
including writing Informed Consent Forms and continued interaction with the IRB
for the life of the study
    Completed paper CRFs as well as Remote Data Entry CRFs
    Designed and implemented recruitment materials, source documents, and
tracking tools to assure adherence to protocols
    Maintained drug accountability logs
    Developed study budgets
    Reviewed study accounts on a monthly basis to stay within budget and not
exceed costs
    Reviewed and edited protocols for orthopedic residents
    Conducted orientation and continuing education for Study Coordinators and
 Research Assistants
    Served as Chairman of the Education Committee for the Research Coordinators
Network at Carolinas Medical Center

Staff Nurse, South East Pain Care (12/1991   “ 04/1996)
Therapeutic areas   “ pain management
    Assisted with set-up of new unit including writing SOPs and Orientation
Manual
    Served as education coordinator for staff and patients
    Responsible for written educational materials to patients and family
    Collected data regarding Lumbar Epidural Steroid Injections, Spinal Cord
 Stimulators and Implantable Intrathecal Medication Infusion Pumps

Staff Nurse, Cardiovascular Recovery Unit (07/1989   “ 12/1991)
Therapeutic areas   “ cardiovascular surgical patients
    Responsible for the care of patients admitted from open heart surgery,
cardiac
 catheterization laboratory, heart transplant and thoracic surgery
    Developed expertise in the use of intra-aortic balloon pumps, left and
right
 ventricular assist devices, automatic internal cardiac defibrillator and
internal and external pacemakers
    Used bedside computer for documentation
    Served on Quality Assurance (QA) Committee

Staff Nurse/Assistant Head Nurse/Acting Head Nurse
Emergency Department
(05/1985   “ 07/1989)
    Provided staffing for the late shift and performance evaluations for
approximately 25 employees including; RNs, LPNs, Nursing Assistants, and clerical
staff
    Assisted in the set up of Adult and Pediatric Trauma Teams
    Lectured to hospitals concerning the trauma network
    Served as liaison between hospital and EMS system
    Coordinated training for EMS personnel

Education

University of North Carolina, Charlotte, NC BSN   “ Nursing

Licensures

NC Nursing License # 089866