Medical Device Registered Nurse
Resume:
Cynthia Ouillette
Email: *********@********.***
Address: *** ****** **
City: Northbridge
State: MA
Zip: 01534
Country: USA
Phone: 508-***-****
Skill Level: Experienced
Salary Range: $95,000
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Cynthia Ouillette, RN, BSN, HP (ASCP) 508-***-****
548 Benson Road, Northbridge, MA 01534 *********@********.***
Background & Objective
As an experienced nurse who has worked in Hematology, Oncology, Critical Care, Urgent Care,
Pediatrics, Home Infusion and Research, I have vast clinical experience and a working knowledge
Of relevant guidelines and clinical practice across a wide spectrum of clinical disease. My experience
In clinical trials gives me the needed skills to successfully coordinate, train and run clinical research
Studies. My goal is to put my comprehensive skill set to work in an equally challenging endeavor.
Professional Experience
University of Massachusetts Medical School/UMass Memorial Medical Center, Worcester, MA
March 2011 to present
Clinical Research Coordinator
Achievement:
* CITI, NIHSS certified; mRS certification pending
* REDCap database Administrator for Study Team
* Overseer of multiple clinical trials at various stages of completion
* Co-Investigator on several clinical trials
* Co-Author on multiple abstracts
Responsibilities:
* Contribute to the development of research protocols
* Gather and submit all required documentation to gain trial approval following strict IRB/FDA guidelines
* Conduct educational sessions with ICU staff
* Evaluate ICU patients for enrollment into appropriate research trial.
* Present a detailed description of the qualifying research trial to the patient
and/or legal representative for possible enrollment
* Perform daily assessments of all drug study subjects, including: drug infusion reconciliation, lab results, monitoring for potential adverse events (AEs) and Transcranial Doppler studies.
* Maintain clinical trial databases
* Adverse Event (AE) / Serious Adverse Event (SAE) management
* Answer any questions posed by clinicians or patient/family related to the ongoing trial
New England Home Therapies, Southborough, MA
August 2009 to March 2011
Infusion Nurse
Achievements:
* Expert access skills including Porta-Caths, PICCs, Central lines, Peripheral
* Skilled in the operation of multiple infusion pumps
* Home patient educator
Responsibilities:
* Travel to patients` homes to carry out MD ordered infusions via peripheral,
Implanted and peripherally inserted central lines
* Performing Initial Home Visits, including intake information, catheter care, self Administration of medication therapy and flushing protocol
* Reporting findings and observations electronically to covering agency
* Assessing patients compliance with therapy and reporting directly to the patients` Doctor any situation that warranted immediate attention
* Filled out Risk Assessment forms as necessary to bring attention to an unsafe Situation in the field
Otsuka America Pharmaceutical, Inc., Rockville, MD
May 2006 to August 2008
Medical Device Trainer / Consultant
Achievements:
* Medical Device Trainer for multiple clinical studies at research sites throughout the US and Canada
* Hemapheresis Practitioner`s Certification
* Co-authored an Oral Abstract presented at the 2008 American Society for Apheresis (ASFA)
Titled, -Evaluating a Comprehensive Training Program to Standardize Treatments and Study
Practices for Apheresis and Non-Apheresis Experienced Nurses in a Multi-center, Double-
Blind, Randomized, Sham Controlled Study-
Responsibilities:
* Traveled to multiple research sites, providing training with ongoing supervision of The clinical staff responsible for conducting study treatments
* Presenter at Investigator, CRO and Sponsor meetings
* Strictly adhered to Sponsor`s Standard Operating Procedures (SOP`s)
* Reviewed all treatment related source documentation at clinical sites
With emphasis on documented AE`s and discussing strategies to avoid future recurrence
* Provided ongoing clinical support and education for study personnel
1) Collaborated on protocol revisions, apheresis device training materials and
Operator`s manuals
2) Performed annual maintenance on medical equipment housed at clinical sites
While maintaining spreadsheets for tracking of said equipment
3) Reviewed, scanned and filed regulatory documents for study at Sponsor location
4) Maintained site and sponsor correspondence in Trial Master Files
5) Contributed ideas and pertinent information to a monthly research study newsletter
Nassau Gastroenterology Associates, Great Neck, NY
May 2005-May 2006
Apheresis Nurse for Medical Device Clinical Trial
Achievements:
Hired by clinical trial Sponsor as an Apheresis Device Trainer
New York RN Licensure
Certified in the Operation of the Clinical Study Apheresis Device
Responsibilities:
* Performed study related apheresis treatments in a busy Gastroenterology
office
* Documented all details of study treatment, including any adverse events, on
source documents and in medical chart
* Completed all study-related tasks as per Sponsor`s Protocol, ICH & GCP
Guidelines and FDA and HIPAA Regulations
* Maintained the integrity of the double-blind clinical trial at all times
* Accommodated study subject`s schedules by remaining flexible with
mine
* Supported the site in adhering to the trial`s protocols
University of Massachusetts Medical Center, Worcester, MA
May 2000-December 2005
Emergency Department Staff Nurse
Achievements:
* RN Supervisor
* Five Years of Service Award
* Designed and implemented reconciliation procedures utilized in the
Emergency Department (ED) for follow-up care of the discharged patient
* Chosen as a mentor to orient new RN hires to the ED
* ACLS, PALS, BLS, ENA and CEDNEP Certification
Responsibilities:
* Provided patient focused care, under the direction of a Physician, to acutely
ill / injured individuals of all ages in a Level One Trauma ED
* Followed prescribed orders of Physician(s) to ensure patient`s recovery
* Worked collaboratively with interdisciplinary team to ensure best possible
outcomes
* Supervised 10 to 12 nursing / ancillary staff in specified areas of the ED
* Trained and supported new RN hires in all areas of the ED
* Provided detailed follow-up instructions for aftercare at home
* Counseled discharged patients, via telephone, with positive test / x-ray
findings
* Performed grief counseling
* Triaged patients to determine level of acuity
Saint Elizabeth`s Medical Center, Boston, MA
February 1999-July 2006
Apheresis Nurse
Achievements:
* Hemapheresis Clinical Specialist Competency
* Collaborated on Investigator initiated clinical trials with a prominent physician in the field of Hematology / Apheresis
Responsibilities:
* Performed therapeutic apheresis procedures in a variety of hospital settings
* Monitored the patient`s vital signs and tolerance of procedure throughout
* Administered immediate and appropriate interventions, as warranted
* Worked closely with medical staff and family members to provide safe and
effective care to the patient with strong emphasis on continuing education
* Mastered peripheral venipunctures and accessing indwelling catheters while
maintaining a clean / sterile working environment
* Performed procedures using Hespan replacement fluid and Bard Cathlink
catheters. These products, already FDA-approved, were trialed for other
indications
* Trained nurses on use of new Apheresis equipment
* Provided ongoing patient education of indwelling catheter care at home
* Maintained scheduling book for out-patient treatments
* Coordinated physician ordered medical visits for patients, as needed
Professional Development Date Completed
* Drug Information Association Seminar (DIA):
Introduction to Good Clinical Practices and Auditing 05/02/2007
* ENA Training 02/06/2001
* CEDNEP 11/22/2000
* HepatAssist LAS Clinical Program 02/12/1999
* Clinical Research Training Seminars (provided by Sponsor) 05/2005 - 8/2008
* Collaborative Institutional Training Initiative (CITI) 03/10/2011
* GCP Re-Training 05/2011
Additional Skills
Proficient in MS Office (Word, Excel, Access, PowerPoint); REDCap database
Proficient on the internet and with email programs
Proficient in VISICU, Hyland, Soarian, Meditech, Readiris Pro applications
Education
Chamberlain College of Nursing, Oakbrook Terrace, IL
RN to BSN Online Degree Completion Program
October, 2008 - February, 2010
Graduated with a BS in Nursing, February, 2010
Massachusetts Bay Community College, Wellesley Hills, MA
AD in Nursing
Dean`s List, Graduated with High Honors
Licensure/Certification
Current Massachusetts Registered Nurse
05/2006-05/2009 Hemapheresis Practitioner`s Certification
03/2007 CRA Certification
05/2006 Medical Device Certification
02/1999 HepatAssist Certification
Research Activities
Pending
Neurocritical: A randomized, prospective, double-blinded, placebo controlled, Phase II trial to
evaluate the safety and efficacy of Deferoxamine Mesylate for the treatment of Intracranial
Hemorrhage (ICH).
Ongoing
Neurocritical: A randomized, prospective, double-blinded, placebo controlled trial to
evaluate the safety and efficacy of Dantrolene for the treatment of moderate to severe
aneurysmal Subarachnoid Hemorrhage (aSAH).
Neurocritical: An observational, prospective study to identify moderate to severe Traumatic
Brain Injured (TBI) patients and track long-term outcome by determining morbidity at
discharge, 3 months and 1 year post injury using outcome scales.
Neurocritical: An observational, prospective study to identify severe Traumatic Brain Injured
patients with Cat Scan evidence of cerebral edema to investigate whether there are genetic
determinants of post-traumatic edema.
Neurocritical: An observational, prospective study to investigate the genetic basis of Reversible Cerebral Vasoconstriction Syndrome (RCVS, -Call-Fleming-Syndrome-) and aneurysmal Subarachnoid Hemorrhage (aSAH) using -exome- capture and deep sequencing.
Completed
Neurocritical: An observational, prospective study to identify neurologic and respiratory parameters in intubated subjects with central nervous system disease in the neurocritical care unit which predict the relative probability of extubation success or failure in that population.
Gastrointestinal: An observational, prospective study to identify clinical, endoscopic
and / or biological predictors that correlate with histopathologic findings in subjects with moderate to severe Ulcerative Colitis.
Gastrointestinal: A randomized, prospective, double-blinded, placebo controlled (sham-controlled) study to evaluate the safety and efficacy of the Adacolumn device for the treatment of moderate to severe Ulcerative Colitis.
Gastrointestinal: A randomized, prospective, double-blinded, placebo controlled (sham-controlled) study to evaluate the safety and efficacy of the Adacolumn device for the treatment of moderate to severe Crohn`s Disease.
Gastrointestinal: A prospective, open-label study to evaluate the Adacolumn device for the treatment of moderate to severe Ulcerative Colitis.
Gastrointestinal: A prospective, open-label study to evaluate the Adacolumn device for the treatment of moderate to severe Crohn`s Disease.
Hematology: Investigator driven, hospital based study to evaluate the safety and efficacy of using an indwelling, tunneled under the skin catheter for outpatient Therapeutic Apheresis procedures.
Hematology: Investigator driven, hospital based study to evaluate the safety and efficacy of using Hespan replacement fluid in Therapeutic Apheresis
Hepatology: A randomized, prospective, multicenter, controlled trial to evaluate the safety and efficacy of the Hepatassist for the treatment of Fulminent Liver Failure / Primary Liver Nonfunctional
Professional Affiliations
Member of the Association of Clinical Research Professionals (ACRP) 2008 - 2010
Member of the Drug Information Association (DIA) 2007 - 2008
Member of the American Society for Clinical Pathology (ASCP) 2006 - 2008
Member of the American Society for Apheresis (ASFA) 2005 - 2008
Member of Phi Theta Kappa Society 1993 - Present
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