project manager, budget and contract, able to meet deadlines

Carol P. Mitchell

Phone: 203-***-****

E Mail: *********@****.***

Professional Experience:

Jan 2011-Present Fairfield County Foot Surgeons

Research Project Manager

Responsible for all research related activity in a private

practice setting. Project Grant writing and budget

coordinating. Assures compliance with FDA, GCP/ICH

guidelines.

March 2012-Present MothersCare Doula Services

Post Partum Doula

Supports the new mother and newborn in a home environment

after delivery. Provides lactation consulting and

instructions on infant care. Cares for the newborn and

mother immediately after birth.

Feb 2013-May 2013 Premier Research International

Regulatory Document Reviewer (contract)

Responsible for retrieval, review, and approval of

regulatory documents required prior to site initiation as

per GCP/ICH and CFR 21 Guidelines.

Nov 2009-Apr2011 Swaddle, Rock and Roll Child Care

Owner

Operates all functions of an in-home Daycare, Supervise,

Accounting: accounts receivables/payables, invoicing, bank

statement reconciliation, and tax prep.

Oct 2009-May 2011 The Pampered Chef

Owner

Operations and Financial handling of direct sales,

kitchenware business.

Jan 2009-Aug 2009 Norwalk Hospital/Norwalk Community College

Director of Clinical Education for the School of

Respiratory Care

Responsible for the operation of the clinical preceptor

program, coordinating clinical rotations and designing

didactic and clinical instruction in accordance to CoArc

accreditation standards.

Dec 2005-Jul 2008 Boehringer Ingelheim

Clinical Research Associate-(Independent Consultant)

Review study design and end points. Create source

documents. Assure studies are conducted on accordance to

GCP/ICH guidelines. Independently coordinates projects and

timelines for key deliverables. Monitors study data for

protocol compliance.

Apr 2006-Jan 2009 State of Connecticut Department of Public Health

Clinical Trial Manager (Easy Breathing Program)

Monitors all regional sites participating in the "Easy

Breathing" research program for disease management in

Pediatric and Adult Allergic Asthma. Responsible for

ensuring site adherence to clinical protocols and FDA

regulations and GCP/ICH guidelines. Assures sites comply

with study timelines. Training of site staff as needed.

Assist sites in developing recruitment strategies.

Performs site selection, monitoring and close out visits.

Creates site visit reports. Processes study data for

monthly State report. Design case report forms and source

documents.

2007-Jan 2009 Norwalk Hospital Norwalk, CT

Acting Director of Clinical Education for the School of

Respiratory Care

Responsible for the operation of the clinical preceptor

program, coordinating clinical rotations and providing

didactic and clinical instruction to prepare students to be

competent respiratory care practitioners.

2003-Jan 2009 Norwalk Hospital Norwalk, CT

Clinical Research Associate/Project Manager

Department of Medicine

Processes regulatory documents, creates research protocols,

manages budgets and contracts, oversees research

coordinators, Assures FDA regulations/ICH/GCP guideline

compliance. Lead and manage research team to ensure

effective completion of project assignments and tasks on

time and within budget. Creates IRB submissions as per

study protocols.

2001-2003 Norwalk Hospital Norwalk, CT

Clinical Research Coordinator

Coordinates research studies for the Dept. of Pulmonary

Medicine. Performs subject recruitment, consent process,

created source documents, manages clinical trial data as

paper CRF or EDC, maintains drug accountability. Obtain,

process, and ship lab specimens. Performs pulmonary

function testing and ECG. Maintains regulatory files,

performs data correction, completes serious adverse event

reports, and attends sponsor evaluation, monitoring, and

close out visits.

1999-2001 Norwalk Hospital Norwalk, CT

Respiratory Therapist

Critical Care, Pulmonary Function Laboratory, Hyperbaric

Medicine, Sleep Disorder Center, Neurology, Pediatrics,

Emergency Medicine, Bronchoscopes, Pulmonary Rehabilitation

1996-1999 Suncare Respiratory Services Stamford, CT

Supervisor, Department of Pulmonary Medicine

5/1997-9/1997 Greenwich Hospital Greenwhich,

CT

Polysomnographer/Staff Therapist

Per-diem

Education/Training:

2/2006 NIH Clinical Research Training Course, Online:

www.nih.gov

3/2005 Strategies for Successful Study Coordination

Workshop, Merck Pharmaceuticals

7/2005 Packaging and Shipping Diagnostic Specimens and Infectious

Substances (IATA), State of Connecticut

8/2005 Clinical Research Coordination Training, Merck Pharmaceutical

1999-2005 University of Connecticut Stamford, CT

Bachelors of General Studies

1994-1996 Norwalk Community College Norwalk, CT

Associates of Science in Respiratory Care

Credentials: Registered Pulmonary Function Technologist (RPFT), 12/1999

Neonatal Pediatric Specialist (NPS), 3/1998

Certified Pulmonary Function Technologist (CPFT), 6/1998

Registered Respiratory Therapist (RRT), 12/1997

Certified Respiratory Therapy Technician (CRTT), 6/1996

Publications: E. Vartany, M. Imevbore, M. O'Malley, C. Manfredi, C.

Pasquarella, L. Scinto, J. Fine: N-terminal Pro-brain

Natriuretic Peptide for Detection of Cardiovascular Stress

in Patients with Obstructive Sleep Apnea Syndrome. J.

Sleep Research (2006) 15, 424-429

S. Gleeson, B. Mitchell, C. Pasquarella, E. Reardon, J. Falsone, L.

Berman: Comparison of FEV6 and FVC for Detection of Airway

Obstruction In A Community Hospital Pulmonary Function

Laboratory. Respiratory Medicine (2006) 100, 1397-1401

Abstract: S. Wainwright, R. Elias, L. Berman, V. Panduranga, K. Topazio,

J. You, C. Mitchell, J.M. Fine: Use of Exhaled Nitric Oxide

in Assessment of Adherence in an Inner City Asthma Clinic

Norwalk Hospital, Norwalk, CT. American Thoracic Society

Confrence2007

E. Vartany,MD, M. Imevbore,MD, M. O'Malley, MD, C.Manfredi,

DO, C. Pasquarella, RRT, L. Scinto, MS, MPA, J. Fine, MD: N-

terminal pro-Brain Natriuretic Peptide for Detection of

Cardiovascular Stress in Patients with Obstructive Sleep

Apnea Syndrome. American Thoracic Society Conference 2005

K. Bookman, M.B. O'Malley, C. Pasquarella, N. Gerken, A.Bruno, J.M.

Fine, E.B. O'Malley: Sleep Deprivation and Off-Duty

Activities in Medical Interns. American College of Sleep

Pathologist, 2004

M.Mauriello, A.Richman, D.Gruen, C.Pasquarella, J.Fine:

Evaluation of Effectiveness of Low Dose CT Scanning for

Lung Cancer Screening In A Community Setting. American

Thoracic Society Conference 2002

Research Experience

2/2007-Jan 2009 Novartis, QAB149B 2335S

2/2007-Jan 2009 Bristol-Myers Squibb, CV185036

3/2007-Jan 2009 Brigham and Women's Hospital, "Physician Alerts to Prevent

DVT and Pulmonary Embolism in Hospitalized Patients"

3/2005-Jan 2009 Norwalk Hospital, Use of Niox testing to Determine

Severity of Allergies

1/2007-Jan 2009 Boehringer-Ingelheim, 205.372

5/2006-Jan 2009 Advanced Life Science, CL05-001

4/2006-10/2006 GSK, MAD103894

8/2005-4/2006 Cephalon "A Phase III, Randomized, Double-Blind, Placebo-

Controlled, Parallel-Group Study to Assess the Efficacy and

Safety of Modafinal Treatment in Children and Adolescents

with Excessive Sleepiness Associated With Narcolepsy"

8/2005-4/2006 Cephalon, #3029

1/2005-9/2005 Merck "A Double-Blind, Randomized, Mulitcenter, Placebo-

Controlled, Parallel-Group Efficacy Study of MK-0928 15mg

and 10mg in the Treatment of Adult Outpatient With Primary

Insomnia"

9/2004-3/2006 Boehringer-Ingelhein, #1012.50

9/2004-5/2006 Merck, "A Double-Blind, Randomized, Placebo-Controlled,

Multicenter, 30-night Polysomnographic Study of MK-0928 in

Adult and Elderly Patients with Primary Insomnia"

10/2004-1/2005 St. Jude Medical, Inc. "Asymptomatic AF and Stroke

Evaluation in Pacemaker Patients and the AF Reduction

Atrial Pacing Trial

11/2004-Jan 2009 Norwalk Hospital, "Use of Exhaled Nitric Oxide to Optimize

Management of Asthma"

10/2003-5/2005 Norwalk Hospital, "Assessing the Measurement of N-Terminal

Pro Brain Natriuretic Peptide and Obstructive Sleep Apnea

Syndrome."

7/2004-2/2006 Altana Pharma, "Effects of roflumilast on exacerbation

rate in patients with chronic obstructive pulmonary

disease. A 52-week, multicenter, double-blind study with

500mcg roflumilast once daily versus placebo"

1/2003-5/2005 Norwalk Hospital, "Variations in Performance and Mood in

Residents Following the Different Types of Days of an On-

Call Month with a Night Float System."

6/2003-10/2004 Norwalk Hospital, "Assessment of Sleep Deprivation Among

Medical Residents."

7/2003-8/2005 Pfizer, "A Randomized, Open Label Multi-Center Trial,

Comparing Microbiological Response to Linezolid and

Vancomycin in Ventilator Associated Pneumonia due to

Methicillin Resistant Staphylococcus Aureus"

1/2003-Jan 2009 Boehringer Ingelheim, 205.235

1/2003-9/2003 Norwalk Hospital, "Utilizing Fev6 as a Surrogate for FVC

in a Community Hospital Pulmonary Function Laboratory."

1/2003-6/2003 IntraBiotics, "A Phase II/III Multicenter, Multinational,

Randomized, Double-Blind, Placebo Controlled Clinical Trial

To Evaluate The Safety And Efficacy Of Isaganan HCL Oral

Solution In Preventing Ventilator-Associated Pneumonia When

Administered To Orally Intubated Patients Receiving

Mechanical Endotracheal Ventilation"

1/2003-5/2003 Inhale Therapeutic Systems, "A Mulitcenter Study to

Characterize the Variability of Pulmonary Function Testing

in Healthy Adults."

2002-2006 Norwalk Hospital, "Assessment of the Response to Oxidative

Stress Patients Undergoing Multiple-Hyperbaric Oxygen

Treatments."

2001-2003 Boehringer Ingelheim, "A Randomized, Double-Blind Placebo-

Controlled 25 Week Trial to Compare the Effects of

Tiotropium Inhalation Capsules Once Daily on Exercise

Tolerance in Patients with Chronic Obstructive Pulmonary

Disease Participating in 8 Weeks of Pulmonary

Rehabilitation"

2002-2003 Sanofi-Synthelabo, "Comparison of Efficacy and Safety of

Zolpidem-MR 6.25mg and Placebo in Elderly Patients with

Primary Insomnia. A Double-Blind, Randomizes, Placebo-

Controlled, Parallel-Group Study"

2001-2/2002 Genentech, "A Multicenter, Randomized, Controlled, Open-Label

Study to Evaluate the Safety of Xolair in Moderate to

Severe, Persistent Asthma Subjects Already Treated With

Other Therapies"

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