Objective

To work in a fast paced, patient care and detailed oriented environment

with an opportunity to use all my skills as well as learn new ones.

Experience

Study Coordinator, Advanced Clinical Research October 2011-

present

Lead Coordinator on several complex and high enrolling studies including

Phase I, II, and III studies: Weight Loss, Hypogonadism, Gout, Diabetes,

CV risks, Hypertriglyceridemia, Asthma, Immunotherapy, and Small and Large

Vaccine Trials.

Back Up Coordinator on several studies including Opioid Induced

Constipation, Chronic Pain, Irritable Bowl Syndrome, and Various Diabetes,

Gout, Migraine, Flu, Dengue Fever and Meningitis Vaccination studies,

Vaginal Atrophy, Over Active Bladder, Hot Flushes and Arthritis studies.

Experience managing and coordinating overnight and "24 hour stay/serial PK

draw" studies.

Extensive clinical background and medical terminology knowledge enabling

thorough but time efficient review of medical histories and identification

of eligibility of subjects.

Working knowledge of IRB and FDA regulations, as well as Good Clinical

Practices.

Prepares updates and reports for management regarding subject enrollment,

recruitment, and retention, as well as deviations and re-trainings for

various staff members that are needed.

Reconciles test article accountability at study close out and prepares

summary report for sponsor.

Creates and maintains excel spreadsheets of patient databases, subject

enrollment for each study, and visit calculators for subjects.

Ensures that subjects stay within window of their visits.

Experience reporting minor and major deviations to the IRB.

Good working knowledge of workflow required for proficient Coordination of

Studies.

Places IV's and obtains blood samples, processes and ships out blood and

urine samples, orders supplies and kits from various reference labs.

Experience with Drug return and Accountability, storage requirements.

Exactness in knowledge of and execution of numerous complex and time

sensitive protocols.

Practices and ensures excellent documentation, including writing CRC

progress notes, ensuring PI writes a progress note, and ensuring that all

labs and AE's are reviewed, assessed, and documented in a timely manner.

Working knowledge of several types of drug dispensing systems and

electronic diary systems, as well as data entry systems.

Proficient in creating source documents for use in Clinical Trials to

enable exactness in protocol execution.

Experience training other CRC's on protocols, lab techniques, EKG's, and

GCP.

Works well with Monitors from several different CRO companies to ensure the

best quality data is obtained.

Experience identifying and reporting Adverse Events, Serious Adverse

Events, and Events of Special Interest.

Able to obtain vitals manually as well as with an automated cuff, EKG

certified on various types of EKG machines, IV certified with experience

using various types of equipment as well as use other equipment related to

various studies.

Development of source worksheets and other study logs and documents for

various studies.

Experience with timely and precise documentation and progress notes for

individual subjects.

Good working relationships with sponsors and study-appointed monitors.

Good Knowledge of Regulatory activities, and manages studies with attention

to regulatory detail.

Experience in QA/QC.

Experience developing good working relationships and report with individual

study subjects.

Experience administering vaccinations using IM and various techniques of ID

injections (including new devices available).

Proficient in Microsoft Office Suite.

Maintains temperature logs for all freezers, refrigerators, and room

temperature medication storage.

Experience with chart review for identification of possible candidates to

enroll in studies.

Able to memorize large amounts of material in a short amount of time,

enabling retention of protocol details from many different studies.

Current CITI certification in GCP and IRB CITI Course in the Protection of

Human Research subjects certificate.

Attends Investigator Meetings off site frequently.

Lead Study Coordinator, Division of Nephrology May 2011- October

2011

Explained and obtained informed consent, medical history and demographics;

documented in source file and maintained with historical data, status

reports, progress notes, and subject log to help ensure subject safety.

Conducted patient visits, obtained vitals, drew, processed, and shipped

blood and urine samples.

Coordinated with pharmacy to dispense medications to patients.

Maintained medication inventory.

Maintained and updated records of all patients contacted about studies.

Data entry and Quality control.

Recruitment and Marketing of studies in accordance with the IRB.

Screened patients for inclusion/exclusion criteria.

Scheduled Patients, made reminder calls.

Determined length of visits and coordinated related facility and equipment

availability.

Reported and tracked adverse events (AE). Reported serious AEs to IRB and

sponsor.

Documented all protocol deviations, reconciled test article accountability

at study close out and prepared summary report for sponsor.

Assessed protocol for clarity and subject safety, reviewed

inclusion/exclusion criteria; clarified concerns and questions with

Principal Investigator and sponsor.

Assisted in writing and maintaining protocols and consents.

Trained in Epic, Powerchart, UTRAC and ERICA (Various Electronic Medical

Records Systems).

Documented all protocol deviations, reconciled test article accountability

at study close out and prepared summary report for sponsor.

Maintained documents as required by FDA guidelines.

Maintained contact with IRB and prepared and submitted IRB documents,

including reviews.

Coordinated the daily operations of research team and maintains adequate

workflow of patients.

Oversaw compliance to protocol, completion and submission of study related

documentation; prepared reports for organizations and agencies.

Monitored enrollment goals and initiates strategies to promote enrollment

and participant compliance.

Coordinated and performed responsibilities related to research participants

including determining subject population availability, developing informed

consents and screening materials, screening and recruiting subjects,

scheduling visits, obtaining informed consent, answering subject inquiries,

overseeing study visits and acting as a liaison between participants and

study-related parties.

Recognized, tracked and reported adverse events and protocol deviations.

Developed and maintained patient databases, investigational logs and

records of drugs administered, medical devices monitored and/or procedures

followed.

Clinical Study Assistant, Cardiovascular Genetics Research Clinic, U of U

February 2010- May 2011

Coordinated Studies between patients and Principal Investigators, and

others involved in studies, assisted in determining protocols and study

design.

Created Source documents and logs.

Performed Recruitment and Marketing of studies in accordance with the IRB.

Served as a liaison between clinics and PI's for recruiting purposes.

Determined visit windows from protocol, scheduled subject visits and sent

visit reminders.

Sent and received lab results to various departments/Sub-Investigators

involved in the study.

Assisted with data analysis and entry.

Sent results and payment to patients.

Prepared and maintained regulatory binders and documents.

Assisted with Quality control.

Consented Patients, both in person and over the phone.

Trained in IRB protocols, UTRAC, and EPIC.

IRB CITI Course in the Protection of Human Research subjects certificate.

Screened and Recruited patients as needed for studies via phone and by

coordinating PR efforts.

Processed and shipped blood and urine samples.

Conducted patient visits, liaison between PI's and patients.

Drew blood, placed IV's, and took vitals, anthropometrics, bioimpedence,

and collected other relevant study data.

IV and Phlebotomy certified.

Maintained and Ordered Supplies.

Health Unit Coordinator, Patient Experience Team Leader, MICU U of U

December 2007- February 2010

Administrative point for Patient Experience.

Planned, made meeting agendas for, facilitate, took minute meetings of, and

reported back to administration of all Exceptional Patient Team Meetings.

Made Goals and follows through to accomplish goals with team members and

other hospital staff with regards to that role, including volunteer

services, customer service, RN staff, Doctors, Patient Education, and other

various committees.

Data reporting and analysis of our monthly satisfaction numbers to staff .

Involved in leadership and facilitating training courses offered through

the University.

Effectively managed the inflow and outflow of patient visitors while

answering phones, taking off doctors' orders and coordinating tests.

Kept the unit stocked with supplies and each room stocked with supplies;

anticipates the needs of doctors and nurses during emergencies.

Allegra, Powerchart and CPOE trained (EMR systems).

Made sure all tests and labs were done on time; goes above and beyond

looking up tests for nurses and making sure they had the right lab tubes

for all tests they didn't know about.

Ensured all unit goals were met for Exceptional Patient Experience, put

together a team for MICU, changed and updated unit bulletin board,

instituted employee recognitions, held monthly meetings and reported out at

staff meetings. Instituted many changes for better patient experiences on

the unit. Raised patient satisfaction scores consistently due to efforts.

Resolved Patient and Family Concerns.

Histotechnologist ARUP, SLC, UT April 2007- December 2007

Assisted physicians and residents with kidney biopsies: including assurance

of maintenance sterile field to ensure a good specimen was obtained.

Processed and embedded tissues of all kinds.

Cut the tissues, put on slides, stain slides with routine staining and then

special staining according to Dr's orders.

Maintain cutting and embedding machines

Managed the processing machines- was "Super User" for machines- sent to

manufacturing site for training. Troubleshot for issues with processing.

Cut 1 hour off of processing time and wrote the protocols for processing

and maintaining machines.

Mixed chemicals for stains according to procedure.

Certified Blood Component Technician, ARUP, SLC, UT January 2006-

April 2007

. Extensive and thorough knowledge of Blood Components and care, including

FDA requirements

. Selection and handling of FFP, Cryo and Platelets for various patients,

and modifications of those products.

. Worked well alone, at night, and under highly stressful situations.

. Worked at Huntsman and PCMC labs as well as U of U labs.

. Able to follow strict procedures at all times without deviation.

Lab Aide U of U Electron Microscopy Lab 2005-2006

. Mixed chemicals and plastics for the preparations of specimens

. Prepared specimens to be processed, processed them

. Cut thick sections of specimens using microtome and stained slides for

selection of thin sections to be cut.

Phlebotomist St Marks Hospital 2003-2005

. Certified Phlebotomist/ Specimen Processor.

. Excellent skills acquiring blood from all ages and types of patients.

. Proficient in heel sticks, finger sticks, line draws and IV placements.

. Excellent neonate phlebotomy skills.

. Carried Code pager and attended all codes in ER and on floors.

. Requested frequently by nurses and patients for draws and hard sticks.

. Requested by nurses for help in placing IV's.

. Promoted to Clinical Lab Assistant and trained new employees.

. Trained in patient registration.

. Processed all specimens, including spinning and aliquotting off samples.

. Trained in PPD/TB skin test placement and reading.

. Also trained and proficient in drug test screening and urine/stool

collection.

. Participated in process improvement for better patient and staff safety.

ACURA Paramedical 2004-2005

. Drew blood, took Urine samples

. Took vital signs and EKG's

. Filled out insurance paper work and obtained medical history.

Phlebotomist- IHC 2002-2003

. Attended IHC's certified phlebotomy training course and became a

certified phlebotomist, and worked in their float pool

Education

University of Utah

BS in Psychology with and emphasis in Health Psychology and Neuroscience,

December 2012

Psychology major with Physician's Assistant prerequisites including

Anatomy, Physiology, Organic Chemistry, Biology, Statistics, Research

Methods, etc.

Chemistry, Human Development, Human Physiology, Microbiology, Anatomy,

Bioorganic Chemistry, Pathophysiology, Biology, Statistics, Research

Methods, etc.

Certifications:

Utah Phlebotomy certification

CPR BLS certified

IV certified

EKG certified

IRB CITI Certified in the Protection of Human Research and Good Clinical

Practices

Contact this candidate