Registered Nurse Medical Device

CARLA "RENEE" CARTER

*** ***** ***** **** #*, Collierville, TN 38017

Telephone: Cellular: 901-***-****; email: **************@*****.***

CAREER OBJECTIVE

A results oriented business leader with extensive communication,

leadership, and technical experience seeking a growth opportunity

position in the biotechnology industry with an emphasis in

Clinical Development of products in the medical device/equipment

or pharmaceutical sectors.

EDUCATION

Union University - Germantown, TN 2007

Bachelor's Degree in Nursing

Northwest Mississippi Community College - Senatobia, MS

2000

Associates Degree: Nursing (Registered Nurse Program)

EXPERIENCE

MEDTRONIC, INC. - MEMPHIS, TN

February, 2012 - Present (Clinical Research Specialist)

Accomplishments

. Oversees, designs, plans and develops clinical evaluation

projects.

. Designs experimental protocols and patient record forms.

. Provides technical services for the collection, review,

maintenance and tracking of regulatory documents from clinical

sites.

. Prepares protocols and conducts clinical studies of products

that have been determined to satisfy a medical need and/or

offer a commercial potential.

. Serves as a medical/scientific consultant to marketing and/or

research project teams and government regulatory agencies.

. Monitors and/or interprets results of clinical investigations

in preparation for new-drug or device application.

. Assist with the resolution of specific site problems as

appropriate.

. Maintain correspondence with site and enter into clinical

administrative database.

. As appropriate, attend periodic training sessions to increase

and maintain knowledge of FDA regulations, drug development

process and regulatory documents requirements.

. Responsibilities include addressing study and site management

and documentation issues of moderate complexity under direct

supervision, utilizing analysis and judgment to effect

solutions to meet goals and objectives.

. May at senior levels, establish the conditions essential for

determining the safety, efficacy, medical usefulness, and

marketability of drug or medical device product candidates.

. Retained study documentation and prepared for archival

. Conducted regularly scheduled meetings with the study team,

identified/assisted with the resolution of any study related

issues

. Communicated with regional colleagues, and Global CDA on issues

resolution, timelines and status updates, contingency or

mitigation plans

CARLA "RENEE" CARTER

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PARKWOOD BEHAVIORAL HEALTH SYSTEM - OLIVE BRANCH, MS

August, 2012 - Present (Staff Nurse)

Accomplishments

. Staffing 6 acute care and residential units - total 110 beds

. Performing chart audits for accuracy and compliance

. Maintain effective communication with management and other members

of the management team.

. May also assume Charge Nurse Responsibilities as required.

. Perform comprehensive nursing assessments on all patients within 8

hours of admission.

. Identify patient problems based upon data collected through

nursing assessment as well as integrating information obtained

through family, significant other and/or primary care giver.

. Assesses educational and spiritual needs. Assesses and

communicates to dietitian any special nutritional or dietary

requirements considering the needs of all patients.

. Assesses patients' major strengths and weaknesses.

. Assesses vital signs and reports all abnormalities.

. Demonstrates proficency in administration of AIMS testing and AIMS

testing protocol.

. Demonstrates clinical understanding of both drug and alcohol

toxicity; consistently and correctly identifies patients in states

of detoxification; identification of withdrawal signs is

consistently correct.

. Formulates nursing plan of care within 8 hours of admission noting

patient needs, age, behaviors and concerns identified through

nursing assessment.

. Analyzes data and develops realistic and measurable short/long

term goals desired outcomes incorporating patient's and family's

goals, when appropriate.

. Actively participates in collaborative treatment team planning for

assigned patients.

. Demonstrates documentation responsibilities in discharge planning,

discharge of patients, AMA discharges, unit to unit transfers and

emergency transfers.

. Participated in the implementation of the treatment plan utilizing

interventions appropriate to the developmental needs of the

patient.

. Assures activities of daily living needs of patients are met.

. Assesses patients in crisis and acts according to ensure patient

and unit safety.

. Accurately maintains medication administration record (MAR).

. Teaches medication management to patient.

SARAH CANNON RESEARCH INSTITUTE - MEMPHIS, TN

August, 2010 - February, 2012 (Clinical Research Coordinator)

Accomplishments

. Support enrolling patients onto clinical trials through

recruitment, screening, enrollment and follow up of eligible

subjects according to protocol requirements

. Developed and maintained strong working relationships with

investigators and study site staff, promoting patient recruitment

strategies

. Reviews study design and inclusion/exclusion criteria with

physician and patient

. Ensures integrity of the data submitted on case report forms or

other data collection tools

. Creates study specific tools for source documentation when not

provided by sponsor

. Generates and tracks drug shipments and supplies as needed

. Responsible for completion of all required documentation according

to site works guidelines

CARLA "RENEE" CARTER

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SARAH CANNON (con't.)

. Assured compliance with GCP/ICH guidelines and FDA regulations,

accuracy of data, drug accountability, query resolution for data

management and clinical site management

. Ability to communicate and work effectively with a diverse team of

professionals

. Collect data for all serious and non-serious adverse events,

report events, and follow-up on events according to protocols.

. Review and verify CRFs and other clinical data for completeness

and accuracy; assist study personnel with query resolution;

conduct 100% source data verification during CRF review/collection

. Assisted with all pre-study, initiation, routine monitoring, and

close-out visits.

. Ability to work independently in a fast pace environment with

minimal supervision at off-site facilities and handle multiple

protocols (up to 15)

. Attend project team meetings and investigator meetings

. Liaison with other vendors

. Retained study documentation and prepared for archival

ST. JUDE CHILDREN'S RESEARCH HOSPITAL - MEMPHIS, TN

July, 2006 - October, 2007 (Radiological Sciences); October 2007 -

August, 2010 (Epidemiology) Clinical Research Associate, RN

Accomplishments

. Coordinate the clinical care and research activities for patients

and families

. Verified patient eligibility and compliance for protocol

requirements

. Monitored case report forms and/or individual patient research

charts

. Prepared adverse event reports

. Prepared for audits of assigned studies

. Assisted in the renewal of grant for protocol

. Processed cytokines for protocol

. Enter protocol specific electronic orders

. Obtained tumor and bone measurements on protocol patients

. Extract data for subjects on protocol schedule to investigators

. Independently summarizes, tabulates and performs analysis of

clinical data. Assists in preparation of material for use in oral

and written presentations.

. Verifies and monitors data quality from hard copies to electronic

database.

. Oversee the Hepatology clinic (scheduling, patient follow-up, and

support to physicians)

. Coordination of clinical trial recruitment, process management,

and related administrative functions.

. Ensure compliance with all regulations, and coordinating start up

related activities for individual trials.

October, 2004 - July, 2006 (Nurse Scheduler)

Accomplishments

. Schedule for patients in the Leukemia/Lymphoma Clinic (A Clinic)

. Presented at the 2005 Cerner Healthcare Conference in Orlando,

Florida for Nurses as Schedulers with manager and one other nurse

scheduler.

CARLA "RENEE" CARTER

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MEMPHIS SURGERY & VASCULAR ASSOCIATES - MEMPHIS, TN

June, 2003 - October, 2004 (Registered Nurse)

Accomplishments

. Nurse for Dr. Virginia McGrath Weaver - Bariatric Program - and

Dr. Hugh Francis, III

. CPT AND ICD-9 Coding/Charging

. Booking surgery cases/tests, precertification, patient

instructions for surgery

. Maintaining patient charts, triage incoming patient calls

. Assisting other physicians in the office with patient

responsibilities

. Assisted with outpatient procedures within the office

LICENSE and CERTIFICATIONS

Society of Clinical Research Associates - Certified Clinical Research

Professional (2009)

IATA Certified

BLS Certified

Registered Nurse - Multi State License (TN)

HONORS

Sigma Theta Tau International, Honor Society of Nursing

COMPUTER SKILLS

Electronic Data Capture (EDC): Experienced in using PhaseForward's

InForm, Medidata Rave, Oracle. Proficient in Microsoft Word, Excel,

Outlook, Power Point, Microsoft Outlook.

Other Recently Used Names: Carla Renee Joyner

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