Curriculum Vitae

Colleen Fisher, M.A, CRC

**** ***** ***** ***

Elk Grove, CA 95758

916-***-****

acbbr4@r.postjobfree.com

I am looking to find a company that will allow me the opportunity to

expand and add to my already extensive knowledge and experience in

t he Research and Healthcare industry and be able to grow with in the

company.

S umma ry of Knowledge and Experience

I have full understanding of complying with FDA Regulations, ICH

Guidelines and following GCP Standards and H IPAA. My experience

has provided me with the opportuni ty to use and work with multiple

medical office devices. Processing Regulatory documents, Knowledge of

P rotocols, Sponsor and FDA audit preparatory. I am able to properly

p rovide documentation of all patient charts and source, Scheduling

patient visits per protocols and MD’s required schedules. I am able to

perform blood draws, injections, process labs as well as certified in

packaging and shipping of biohazard substances. I am able to perform

t hese duties accurately and in a t imely manner.

E ducation Florin H igh School, Sacramento, CA

Diploma, GPA 4.0

2004 Graduate of Western Career College, Sacramento,

CA

Certified Medical Assisting Certificate Program, GPA 4.0

Awards Deans List

Honor Awards in Laboratory, Clinical, Administrative

Mentor to New Students Injections Card

Perfect Attendance Award CPR Certified

Experience Clinical T r ials Research, Sacramento, CA

S ite Manager/Lead Coordinator, Ma rch 2013 –

October 2013

Duties include: Processing Regulatory documents,

K nowledge of Protocols, Sponsor audit preparatory, proper

documentation of all source, blood draws and lab

p rocessing, Drug accountability, Completing EDC

accurately in a timely manner, complying with

Regulations and Guidelines.

C apital Nephrology Clinical Research,

Sacramento, CA

Site D i rector/C R C, 8/2009-3/2013

Duties include: Processing Regulatory documents,

Completing Study budgets, Supervising 3 CRC’s and a

CRC assistant, Ensuring office devices are calibrated,

K nowledge of Protocols, Sponsor audit preparatory,

ensuring proper collection and documentation of source,

D rug accountabili ty, EDC completed accurately in a

t imely manner, complying with FDA Regulations, ICH

Guidelines and following GCP Standards.

N orthe rn California Research Corporation,

Sacramento, CA

Clinical Research Coordinator, 12/2006- 7/2009

Duties include: Knowledge of Protocol for each study,

Recruitment, Screening, proper documentation of all

s tudy subjects and source, Scheduling patient visits per

p rotocol, Vitals, ECG’s and Venipuncture, Labs, Drug

accountabili ty, Completing paper CRF’s and EDC

accurately and in a timely manner, complying with FDA

Regulations, ICH Guidelines and following GCP

S tandards.

Clinical T r ials

Endocrine

A Mul ti-Center, Double-Blind, Placebo-Controlled

Comparison of Multiple Doses of Esterified Estrogens and

Methyltestosterone, In Combination and Alone, in

Relieving Vasomotor Symptoms In Postmenopausal

Women.

A Randomized, Double-Blind, Placebo and Active

Comparator- Controlled Parallel-Group Study of the

E fficacy and Safety of XXX as Monotherapy Treatment of

T ype I I Diabetes Mellitus.

A 12-Week, Mul ticenter, Randomized Parallel-group,

Double-blind, Placebo-controlled study to Evaluate the

t reatment effect of XXX compared with placebo in Adult

patients with Type I I Diabetes, and Renal Impairment

( Moderate, Severe, and End-Stage) with an additional 40-

week, Randomized, Parallel-group, Double-blind, placebo-

controlled long term observation period.

I nhaled Mealtime Insulin with the XXX Plus OAD versus

OAD alone in Type 2 Diabetes: A 26-Week, Open-Label,

M ul ticenter, Randomized. Parallel Trial to Investigate

Safety and Efficacy.

A 24-Week, Blinded, Randomization, Placebo-Controlled

dose ranging t rial of XXX for weight loss in healthy obese

patients.

Cardiovascular

A phase 3, Double-Blind, Randomized, Placebo-Controlled

s tudy to evaluate the efficacy and safety of XXX in

subjects with Essential Hypertension. Evaluate the safety

and effectiveness of three doses of the investigational drug

X XX, as compared to placebo and to XXX.

An 8 month phase 3, Open-label study with a blinded reversal phase to

evaluate the safety and tolerability of XXX in subjects with essential

H ypertension. Evaluate the effectiveness, safety and tolerability of

X XX and XXX plus chlorthalidone in subjects with high blood pressure.

G astrointestinal

A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety

Of XXX in Subjects Requiring NSAID Treatment.

A 12-week, Randomized, Mul ti-Center, Double-Blind, Dose-

Ranging,

Placebo-Controlled Study of XXX in Subjects with I r r i table Bowel

Syndrome.

A Randomized, Mul ti-Center, Double-Blind, Placebo-Controlled, Dose

Range Finding, Parallel-Group, Phase 2 Trial of Oral XXX

A dministered To Patients with Chronic Constipation.

A Mul ti-Center, Randomized, Placebo-Controlled, Double-Blind Study

of the Efficacy and Safety of XXX in Patients with Opioid-Induced

Bowel Dysfunction.

Extension Study,

A Mul ti-Center, Open-Labeled Study of the long-Term Safety and

E fficacy of XXX in Patients with Opioid-induced Bowel Dysfunction.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-

Group T rial of XXX Administered Orally to Patients for 12 weeks

Followed by a 4-Week Randomized Withdrawal Period in Patients with

Chronic Constipation.

An Open-Labeled, Long-term Safety Study of Oral XXX Administered

to Patients with Chronic Constipation or I r r i table Bowel Syndrome

w ith Constipation.

A 12-Week, Randomized, Double-Blind, Dose Ranging, Placebo-

Controlled Study of XXX in Subjects with I r r i table Bowel Syndrome.

A Randomized, Double-Blind, Parallel study of XXX versus XXX for

Healing and Symptomatic relief of Moderate to Severe Erosive Gastro

esophageal Reflux Disease.

M usculoskeletal

A Mul ti-Center, Randomized, Double-Blind, Placebo-Controlled Study

w ith an Open-Label Run-in to Access the Efficacy, Tolerability, Safety

of XXX Compared to Placebo in Opioid-Naïve Subjects with Moderate

to Severe, Chronic Low Back Pain.

A Mul ti-Center, Randomized, Double-Blind, Placebo-Controlled Study

w ith an Open-Label Run-in to Access the Efficacy, Tolerability, and

Safety of XXX or XXX Compared to Placebo in Opioid-Naïve Subjects

W ith Moderate to Severe Chronic Pain due to Osteoarth ri tis of the

K nee.

A Phase 3, Tit ration followed by a Randomized, Double-Blind Study of

Controlled Release XXX Compared to Placebo in Patients with Chronic

Low Back Pain.

Neurological

A Phase 3 Mul ti-Center, Randomized, Double-Blind, Placebo-

Controlled Study of the Safety and Efficacy of XXX in the Treatment of

Patients with Postherpetic Neuralgia.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group

S tudy Evaluating the Efficacy and Tolerability of Oral XXX 300mg

T ID, a Glial Cell Modulating Agent, Versus Placebo in the Treatment

of Post Herpetic Neuralgia.

A Mul ti-Center, Randomized, Double-Blind Study to Compare the

E fficacy and Safety of Patient-Ini tiated XXX Twice Daily for One Day

Versus XXX Twice Daily for 3 days in Immunocompetent Adults with

Recurrent Genital Herpes.

Skin

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-

Center, Efficacy and Safety study of XXX in the Treatment of External

Genital Warts.

A M ul ti-Center, Phase 3 Study to Evaluate XXX, A Novel Malathion

Gel 0.5% Formulation for the Control of Head L ice in Pediatric

Subjects and Adult Subjects with Pediculosis Capitis.

South Area Pediat rics, Sacramento, CA

Office Manager F ront/Back Office

Duties Included: Facilitating a schedule containing four Doctors, Six

Medical Assistances and a minimum of 36 patients a day. Mul ti-

Tasking between Administrative duties: billing, insurance verification,

referrals, ordering supplies and maintaining AR/AP. Medical duties:

patient relations, assisting MA’s with back/front office duties, and

p roducing High Standards and Productivity from staff through Positive

communication and feedback.

Dr. R. Jackson/Dr. G. Heise, Sacramento, CA

Receptionist/Back Office MA

Duties included: Patient check-in, New Patient Charting, Answering

M ul ti-L ine Phones, Filing, preparing Patients for surgeries, t ray set-

up, preparing Medication and IV’s, assist Dr.’s during surgeries and

S terilization.

F r uit r idge Medical Center, Sacramento, CA

F ront/Back Office/Therapist

Duties Included: Charting, Multi-Line Phones, Billing, Therapy, X-Ray

and Development.

M ilhous Child ren’s Services, Sacramento, Ca

Supervisor/ Counselor

Duties Included: Facilitating all Administrative duties, Scheduling, Six

E mployees, Administering Medication to Residents, Running Group

S tress Management Session and Reporting to Corporate Office.

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