Manager Safety

D AMIEN HALL

***** ********* **** ***** #***

TAMPA, FL 33626

abnoug@r.postjobfree.com

813-***-**** cell

813-***-**** home

OBJECTIVE

To implement and put into action Healthcare Specialist and Bilingual Clinical Research

Coordinator/Study Manager skills within both inpatient and outpatient Phase I-IV Global CNS,

Opiate, Pain Management, NCI/NIH funded and Oncology Clinical Research Trials, experience

and medical expertise.

SKILLSET

Data Capturing, Networking, Computer literate, Non-Abbreviated Work Hours, Reliable, Smart

Worker, among other skills and abilities

EDUCATION

Almeda University- Online 2008

Bachelors Degree, Business Administration

Healthcare Project Management

American Intercontinental University Online 2007

Associates Degree, Business Administration-Healthcare Project Management

United States Navy, Barbers Point, Hawaii

Executive Aviation Supply Management Military Training

United States Navy, Great Lakes, Illinois

Basic Naval Training/Hospital Corpsman Training

Diversity Committee Member, University of South Florida

Current member of ACRP, preparing for September 2009 Exam

TRAINING

CITI Certification, InForm, Impala, IVRS, Medidata, ClinPhone, OmniComm

Certificate: NIH Participation of Human Research Participants, CITI

NASBP Member

LANGUAGE(S)

English (Primary)

Spanish (Intermediate)

PROFESSIONAL EXPERIENCE

UNIVERSITY OF SOUTH FLORIDA 4/09-PRESENT

CLINICAL RESEARCH ADMINISTRATOR/STUDY MANAGER

As the first coordinator in the College of Nursing to possess both inpatient and

outpatient research experience, managed research project databases, developed flow

sheets and other study related documents.

Drafted and completed source documents/Case Report Forms within both Phase I-IV

NIH-grant funded and Pharmaceutical Clinical trials in Oncology.

Interfaced with Research Participants, determined eligibility and categorized Study

Participants according to protocol.

Assisted in the development of recruitment strategies and performed screenings for

Study Participants including interviews and questionnaires.

Supervised collection of study specimens and processing.

Established case packages for study procedures, monitored scheduling of procedures

and charges, and coordinated other services as needed.

Ensured compliance with research protocols, reviewed Case Report Forms and audits

for accuracy with source documents.

Orchestrated weekly and monthly staff and team Investigator meetings.

Prepared regulatory submissions.

Mentored and managed junior personnel.

Independently managed significant and key aspects of a large clinical trial or all

aspects of one or more small trials.

Provide leadership in determining, recommending, and implementing improvements to

policies/processes. Performed related responsibilities as required.

CETERO RESEARCH/ALLIED RESEARCH INTERNATIONAL 12/08-2/09

CLINICAL STUDY MANAGER

One of 9 Study Managers to possess both inpatient and outpatient research experience,

managed research project databases, developed flow sheets and other study related

documents for Phase I-IV, Bioavailability and Bioequivalence Clinical Trials .

Completed source documents/Case Report Forms within both Phase I-IV NIH-grant

funded and Pharmaceutical Clinical trials in various Phase I-IV, Bioavailability and

Bioequivalence Clinical Trials.

Interfaced with Research Participants, determined eligibility and categorized Study

Participants according to protocol.

Assisted in the development of recruitment strategies and performed screenings for

Study Participants including interviews and questionnaires.

Supervised collection of study specimens and processing.

Established case packages for study procedures, monitored scheduling of procedures

and charges, and coordinated other services as needed.

Ensured compliance with research protocols, reviewed Case Report Forms and audits

for accuracy with source documents.

Attended monitoring meetings with sponsors.

Prepared regulatory submissions.

Independently managed significant and key aspects of a large clinical trial or all

aspects of one or more small trials.

Due to company reorganization based from a significant decrease in business, I was laid

off in February, 2009.

MOUNT SINAI MEDICAL CENTER/COMPREHENSIVE CANCER CENTER 10/08-12/08

CLINICAL RESEARCH COORDINATOR/STUDY MANAGER

As one of three Coordinators to possess both inpatient and outpatient research

experience, managed research project databases, developed flow sheets and other

study related documents.

Completed source documents/Case Report Forms within both Phase I-IV NIH-grant

funded and Pharmaceutical Clinical trials in Oncology.

Interfaced with Research Participants, determined eligibility and categorized Study

Participants according to protocol.

Assisted in the development of recruitment strategies and performed screenings for

Study Participants including interviews and questionnaires.

Supervised collection of study specimens and processing.

Established case packages for study procedures, monitored scheduling of procedures

and charges, and coordinated other services as needed.

Ensured compliance with research protocols, reviewed Case Report Forms and audits

for accuracy with source documents.

Attended monitoring meetings with sponsors.

Prepared regulatory submissions.

Independently managed significant and key aspects of a large clinical trial or all

aspects of one or more small trials.

Due to company reorganization, I was laid-off in December, 2008.

SEGAL INSTITUTE FOR CLINICAL RESEARCH 12/05-10/08

CLINICAL RESEARCH COORDINATOR/CLINICAL STUDY MANAGER

Handled administrative activities associated with the conduct of clinical trials.

Provided guidance to less experienced staff.

Managed research project databases, developed flow sheets and other study related

documents and completed source documents/Case Report Forms.

Interfaced with Research Participants.

Determined eligibility and consents for Study Participants according to protocol.

Approved orders for supplies and equipment maintenance.

Assisted with the development and recruitment strategies in conducting screenings of

Study Participants, including interviews and questionnaires.

Supervised collection of study specimens and processing.

Established case packages for study procedures.

Monitored scheduling of procedures and charges, and coordinated other services as

needed.

Ensured compliance with research protocols, reviewed Case Report Forms and audits

for accuracy with source documents, and attended monitoring meetings with sponsors.

Prepared regulatory submissions.

Independently managed significant and key aspects of a large clinical trial or all

aspects of one or more small trials.

Trained and provided guidance to less experienced staff.

Oversaw data management for research projects.

Interfaced with Research Participants and resolved issues related to study protocols.

Authorized purchases for supplies and equipment maintenance.

Determined effective strategies for promoting/recruiting research participants and

retaining participants in long term clinical trials.

Periodically audited Operations including laboratory procedures to ensure compliance

with applicable regulations.

Provided leadership in identifying and implementing corrective actions/processes.

Monitored IRB submissions and responded to requests and questions.

Interfaced with Study Sponsors, Monitors and reports AE/SAEs.

Resolved Study Queries.

Provided leadership in determining, recommending, and implementing improvements

to policies/processes. Performed related responsibilities as required.

SEGAL INSTITUTE FOR CLINICAL RESEARCH 12/04-12/05

RESEARCH ASSISTANT/STUDY COORDINATOR

Responsibilities included ECGs, phlebotomy, completing requisition forms, packaging

and shipping of lab specimens; transporting specimens, monitoring and recording of

temperatures of –20 C freezer and room temperatures along with transcribing data into

case report forms.

ORLANDO REGIONAL MEDICAL CENTER/SAND LAKE HOSPITAL 9/02-12/04

ORLANDO, FLA.

ADVANCED CLINICAL TECHNICIAN

Used and displayed mentoring skills and abilities learned while serving in the Navy as a

Hospital Corpsman.

Earned leadership capacity that permitted me to obtain vital signs, perform difficult

lab draws, transferred patients, performed and interpreted EKGs, Diabetic glucose/

urine checks, measured intake/output from patients.

Assisted the RN/LPN with dressing changes, basic wound care, catheter

insertion/removal/

Reported abnormal vitals and behaviors to RN/LPN or Physician to assist in the overall

treatment and care of complex patients within the Med/Surgical,

Cardiology/Cardiothoracic, ICU environments.

UNIVERISTY OF MICHIGAN, ANN ARBOR, MI 1/02-9/02

HEALTHCARE SPECIALIST

Obtained vital signs, prepared exam rooms, set-up referrals and handled patient

scheduling.

Assisted with minor surgical procedures such as Mole Punch Biopsies, Vasectomies and

Colposcopies.

Assisted Sports Medicine Physicians by arranging stress testing, back manipulation,

School physicals and giving injections/vaccinations.

ASSOCIATES IN MEDICINE, BERKLEY, MI 1/99-1/02

SENIOR HEALTHCARE SPECIALIST

Assisted Doctor with minor Thyroid Biopsy, called in prescriptions, organized patient

charts, answered phone lines, completed insurance billing and coding, obtained vital

signs, conducted urine/blood testing in order to aid Physicians in the proper treatment

and diagnosing of patients.

UNITED STATES NAVY 12/94-12/98

BARBERS POINT, HI/GREAT LAKES, IL

HEALTCARE SPECIALIST/EXECUTIVE SUPPLY MANAGER

Responsible for the overall inventory, purchase, issue and receipt of 20 SH-60B

helicopter parts which was in excess of 100 million dollars, learned how to lead in

times of mass casualties.

Performed minor surgical procedures, usage of medicine such as Atropine and

Ephedrine, learned about x-rays, vital signs and various other methods in healthcare.

Maintained an overall mission readiness score of 98%-the highest in the Pacific.

CLINICAL RESEARCH

CLINICAL RESEARCH ASSISTANT FOR CLINICAL RESEARCH STUDIES

4/09-present

An NCI/NIH funded Clinical Trial using MBSR (Mindfulness Based Stress Reduction) Therapy in

Stage 0-3 Breast Cancer Survivors

An NCI/NIH funded Clinical Trial evaluating cost-effective measures in patients who use MBSR

Mindfulness Based Stress Reduction) Therapy

4/08-1/09

A Phase IV, Double Blind, Placebo-Controlled, Randomized, Flexible-dose Study of the Safety

and Efficacy of Intradermal (Study Drug) in Adolescents with Major Depression

10/08-1/09

Phase II Trial, Treatment in High-Risk (Study Drug) and Low Risk (Study Drug) for Adjuvant

Rectal and Colon Cancer

10/08-1/09

Phase II Trial in Treatment of (Study Drug) in Patients with Adjuvant Rectal Cancer

10/08-1/09

Phase II Trial with Accelerated Radiation Plus (Study Drug) for Treatment in Patients with

Oropharynx, Hypopharynx or Larynx Cancer

10/08-1/09

Phase III Trial with (Study Drug) in Patients with Metastatic or Recurrent Head and Neck Cancer

10/08-1/09

Phase IV Trial with (Study Drug) in Patients with Metastatic Colon Cancer

10/08-1/09

Phase II Trial Involving Cytogenetic Studies in Patients with Acute Leukemia

5/08-1/09

(Study Drug) for the Treatment of Cocaine Dependence: A Phase II Study

8/08-1/09

(Study Drug) for the Treatment of Methamphetamine Dependence: A Phase II Study

9/07-5/08

A Phase II, Randomized, Double-Blind Placebo-Controlled, Multi-center Study of (Study Drug) in

Patients with Opioid Dependence.

10/08-1/09

A Single Cross-Over, Open Label Study of the Relative Bioavailability of (Study Drug) Versus

Buprenorphine Sublingual Tablets at Steady State in Patients with Opioid Dependence

10/06-1/09

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Efficacy and Safety

Study of (Study Drug) for Inhalation in Schizophrenia Patients with Agitation

8/06-1/09

A Randomized, Double-Blind Study of (Study Drug) vs. (Study Drug) in the Treatment of

Schizophrenia

8/06-1/09

A Three-Week, Double-Blind, Multi-Center, Placebo-Controlled Study Evaluating the Efficacy

and Safety of Add-On Oral (Study Drug) in Subjects with Acute Mania Treated with (Study Drug)

or (Study Drug)

8/06-1/09

A Phase III, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and

Efficacy of (Study Drug) in Subjects Completing Trial (Study Drug) and Continuing (Study Drug)

for the Treatment of an Acute Manic or Mixed Episode

8/06-1/09

A Phase III, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and

Efficacy of (Study Drug) in Subjects Continuing (Study Drug) for the Treatment of an Acute

Manic or Mixed Episode

5/06-1/09

A Randomized, Double Blind, Placebo-Controlled, (Study Drug)-Referenced, Parallel-Group,

Safety, Efficacy and Tolerability Study of (Study Drug) vs. Placebo in Subjects with Acute

Exacerbations of Schizophrenia

4/06-1/09

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multi-Center

Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release (Study

Drug) (3, 6 and12mg/day) in the Treatment of Subjects with Acute Manic and Mixed Episodes

Associated with Bipolar I Disorder

6/05-9/05

A Phase II, Randomized, Multi-Center, Double-Blind Placebo-Controlled, Single-Dose

Comparison of the Analgesic Activity of (Study Drug) and Placebo in Subjects with Shoulder Pain

11/05-3/06

A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Adaptive,

Dose-Range Study to Evaluate the Safety and Efficacy of (Study Drug) Administered Once Daily

for 12 Weeks in Adults with Schizophrenia

8/05-1/09

A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of (Study Drug)

Injected in the Deltoid or Gluteus Muscle in Schizophrenia

8/06-1/09

A Randomized, Double-Blind Study of (Study Drug) vs. (Study Drug) in the Treatment of

Schizophrenia

8/06-1/09

A Phase II, Three-Week, Double-Blind, Multi-Center, Placebo-Controlled Study Evaluating the

Efficacy and Safety of Add-On Oral (Study Drug) in Subjects with Acute Mania Treated with

(Study Drug) or (Study Drug)

8/06-1/09

A Phase III, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and

Efficacy of (Study Drug) in Subjects Completing Trial (Study Drug) and Continuing (Study Drug)

for the Treatment of an Acute Manic or Mixed Episode

8/06-1/09

A Phase III, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and

Efficacy of (Study Drug) in Subjects Continuing (Study Drug) for the Treatment of an Acute

Manic or Mixed Episode

5/06-1/09

A Randomized, Double Blind, Placebo-Controlled, (Study Drug)-Referenced, Parallel-Group,

Safety, Efficacy and Tolerability Study of (Study Drug) vs. Placebo in Subjects with Acute

Exacerbations of Schizophrenia

4/06-1/09

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multi-Center

Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release (Study

Drug) (3, 6, and 12mg/day) in the Treatment of Subjects with Acute Manic and Mixed Episodes

Associated with Bipolar I Disorder

11/05-3/06 A Multi-Center, Double-

Blind, Double-Dummy, Placebo-Controlled, Randomized, Adaptive, Dose-Range Study to

Evaluate the Safety and Efficacy of (Study Drug) Administered Once Daily for 12 Weeks in

Adults with Schizophrenia

9/05-03/06

A Double-Blind, 40 Week Continuation Study Evaluating the Safety of (Study Drug) and (Study

Drug) in the Treatment of Subjects with Acute Mania

8/05-5/06

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to

Evaluate the Efficacy and Safety of 3 Fixed Doses of (Study Drug) in Subjects with

Schizophrenia

4/05-11/05

A Multi-Center, Double-Blind, Flexible-Dose, 6 week Trial of the Efficacy and Safety of (Study

Drug) Compared with Placebo using (Study Drug) Positive Control in Subjects with an Acute

Exacerbation of Schizophrenia

4/05- 12/05

A Multi-Center, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and

Maintenance of Effect of (Study Drug) using (Study Drug) Positive Control in Subjects who

Complete Protocols

3/05- N/A

A Double-Blind, Phase III, Two Week, Placebo-Controlled Study of (Study Drug) for the Relief of

Constipation Due to Opioid Therapy in Advanced Medical Illness

3/05- N/A

A Three Month, Open-Label Treatment Extension of (Study Drug)

2/05- N/A

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of (Study Drug) in the

Treatment of Subjects with Agitation or Psychosis of Alzheimer’s disease

2/05- 1/06

A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and

Efficacy of (Study Drug) vs. (Study Drug) and Placebo in In-Patients with an Acute Manic

Episode

2/05- 01/06

A Double-Blind, 9 Week Extension Study Evaluating the Safety and Maintenance of Effect of

(Study Drug) vs. (Study Drug) in the Treatment of Subjects with Acute Mania

2/05-1/09

A Randomized, Double-Blind, Placebo-Controlled and (Study Drug)-Referenced, Parallel-Group

Efficacy and Safety of Two fixed Doses of (Study Drug) in the Treatment of Schizophrenia

2/05-9/05

A Randomized, Double-Blind, (Study Drug)-Referenced, Parallel-Group Efficacy and Safety of

Flexible Doses of (Study Drug) in the Long Term Treatment of Schizophrenia EXT.

2/05-9/05

A Pharmacoeconomic Study carried out in Connection with the (Study Drug) Clinical Trials

2/05-10/05

A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel-Group

Study of the Efficacy and Safety of (Study Drug) vs. Placebo and (Study Drug) in Patients with

Schizophrenia

2/05- 5/05

A Placebo and Positive-Controlled, Randomized Study Evaluating QT and QTc Intervals

Following Administration of Immediate-Release (Study Drug) in Subjects with Schizophrenia or

Schizoaffective Disorder

2/05- 10/05

An Open-Label, Multi-Center, 12 Month Study of Long-Term Safety and Tolerability of (Study

Drug) in Patients with Schizophrenia

12/04 – 1/05

A Double-Blind, Placebo-Controlled Pilot Tolerability Study of Intramuscular (Study Drug) in the

Treatment of Acutely Agitated Patients with a Diagnosis of Alzheimer’s, Vascular or Mixed

Dementia

12/04 – 3/06

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Effectiveness of

(Study Drug) in Nursing Home Residents with Moderate to Severe Alzheimer’s Disease

12/04 – 05/06

A One Year, Multi-Center, Randomized, Double-Blind, Placebo- Controlled Evaluation of the

Efficacy and Safety of (Study Drug) In Subjects with Mild Cognitive Impairment

OTHER CERTIFICATIONS/TRAINING

Hazmat Certification 04/2005- 04/2010

ACRP Membership 09/2007-current

NIH Certificate # 27946: Protecting Human Research Participants

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