Clinical Research Medical

ESOTERICA L. BERRY, ADN, BS, CCRC

**************@*****.*** 804-***-****

8021Professional Summary:

I am an accomplished and energetic Research Professional, with a solid history of achievement in Clinical Research. Associated with Pharmaceutical Industry for more than 8 years. Different roles I’ve worked on are nursing, Phlebomist/Medical Lab Technologist, Clinical Research Coordinator and Research Coordinator Manager. Proficient in GCP ICH guidelines. I Possess knowledge of medical terminology, clinical requirements and procedures. Proficient in handling medical tools, apparatus and equipment's. Conduct several medical tests. Conducted research activities to assist pharmaceutical drug approval. Engage in Activities related to nursing and drug development. Motivated leader with strong organizational and prioritization abilities. Areas of expertise include monitoring of documents, great attention to detail, and communication, organizational skills, and Regulation Compliance. Capable of adjusting to any work environment, and willing to take on any task. I’m capable of working well independently as well as with a team.

SKILLS

Social Perceptiveness Coordination

Critical Thinking Operation Monitoring

Time Management Judgment and Decision Making

Monitoring Active Learning

Clerical Management of Material Resources

Education and Training Microsoft Outlook, Excel, PowerPoint

Experience

Eurofins Lancaster Laboratories Lancaster – June-2015- June-2017 Lancaster, Pennsylvania

Clinical Research Coordinator / Regulatory for Altria Client Services LLC

Review and monitor CRO documents for compliance

Knowledge of FDA regulations, and guidelines

Review of site documents. Assure GCP compliance.

Retention, Management, and archiving of TMF documentation

Assure Regulatory GCP compliance.

QC and Audit data reports from monitoring, regulatory document review from site and CRO,

EDC review, test product management, Manage Trial Master File upon CR release

Support Clinical Research Study Managers.

Review and reconciliation of Budget Invoices for Accuracy prior to payment.

Regulate and QC saved files in Sponsor Data base.

Assist in SOP development and maintenance.

Assist in team infrastructure, monitor weekly progress reports, meeting agendas and minutes for accuracy.

Schedule and facilitate team meetings

Prepare tables, graphs, fact sheets, and written reports summarizing research results

Edit and submit protocols and other required research documentation.

TMF Management, review and approval on Sponsor level

Product Integrity submissions and recommendations

Perform needs assessments and/or consult with clients in order to determine the Project needs

Synergy Trials - Site Operations Manager/ Site startup/Project Coordinator 02/2014 to 06/2015

Hopewell, VA.

Served as site Manager for 3 Clinical Research sites.

Site start up readiness, study start documents preparation.

Selected research studies to perform at sites, assisted in budget and contracts.

Trained all new coordinators.

Assured compliance of GCP guidelines, and sites SOP maintenance Assured Quality Data is performed daily.

Site File Management and auditing

Assisted Physicians with proper training of Studies .Regulatory submissions and Compliance.

Use computers for various applications, such as database management or word Processing.

Create, maintain, and enter information into databases.

Retention, Management, and archiving of Site Master File documentation

Updating and maintaining documents, such as attendance records, Correspondence, or other material.

Site Master file Management and auditing

Complete IRB forms in accordance with company procedures.

Review work completed by coordinators to check for correct spelling and grammar, ensure company format policies are followed, and recommend revisions.

Clinical Research Partners, LLC, Site operations Manager, Research Coordinator 07/2012 to 03/2015 Richmond, Virginia

Tremendous research aptitude with knowledge of Clinical research Phases 2-4.

Extraordinary ability to maintain quality performance for long working hours.

Overseen site coordinators and trained new staff.

Conducted Patient visits and education.

Trained staff on phlebotomy techniques.

Retention, Management, and archiving of Site Master File documentation

EDC date entry, Good communication and comprehension skills.

Proficient in GCP ICP guidelines.

SOP maintenance and training, site improvement initiative.

Study start up activities preparation for Site initiations

Perform payroll functions, such as maintaining timekeeping information and submitting payroll.

Create, maintain, and enter information into databases.

Set up and manage paper or electronic filing systems, recording information, Updating paperwork, or maintaining documents, such as attendance records, Correspondence, or other material.

Maintain scheduling and event calendars for Physicians.

Site Master file Management

Compose, type, and distribute meeting notes, routine correspondence, or reports, Such as presentations or expense, statistical, or monthly reports.

Establish work procedures or schedules and keep track of the daily work of Research staff.

Manage projects or contribute to committee or team work.

Prepared and audit documents for FDA audits

Dominion Medical Associates - Clinical Research Dept Lead / Nurse 01/2007 to 01/2012

oRichmond, Virginia

Possess knowledge of medical terminologies, clinical requirements and procedures

Proficient in handling medical tools, apparatus and equipment's, required to

Conduct several medical tests .Ability to multitask and respond to the needs and Pressure situations promptly.

High understanding and patience levels that help to ease out the patient's worries And anxieties

Capability to manage and coordinate several activities efficiently

Provide support to the head physician in administering medications to patients accurately and promptly.

Communicate with the patients to document medical history.

Write prescriptions and sign off on prescription fax request.

Patient education.

Patient referrals to other physicians and services

Conducted research activities to assist pharmaceutical drug approval.

Use computers for various applications, such as database management or word Processing.

Answer telephones and give information to callers, take messages, or transfer calls to appropriate individuals.

Monitor, record, and report symptoms or changes in patients' conditions.

Record patients' medical information and vital signs.

Conduct specified laboratory tests.

Prepare rooms, sterile instruments, equipment, or supplies and ensure that stocks of Supplies are maintained.

Prescribe or recommend drugs, medical devices, or other forms of treatment, such, as physical therapy, inhalation therapy, or related therapeutic procedures.

Engage in research activities related to nursing.

Laboratory Corporation of America – Phlebotomist/Medical Lab Technologist 01/2004 to 01/2007

Richmond, Virginia

Collect blood and urine specimens.

Ensures all field phlebotomy and specimens are collected accurately and on time.

Perform capillary and venous venipunctures on pediatric and geriatric patients.

Maintain patient confidentiality while following procedures as stated in manual.

Perform finger sticks to check the hemoglobin and glucose of various patients.

Hematology and Oncology specimen

Labels, centrifuge, split, and freeze specimens as required by test order.

Schedule and Disposes of biohazard materials when scheduled.

Conduct chemical analyses of body fluids, such as blood or urine, using microscope and automatic analyzer to detect abnormalities or diseases and enter findings into Computer.

Set up, maintain, calibrate, clean, and test sterility of medical laboratory Equipment

Collect blood or tissue samples from patients, observing principles of asepsis to obtain blood sample.

Perform medical research to further control or cure disease, hematology and Oncology Pactice

oSupervise or instruct other technicians or laboratory assistants.

Nephrology Specialists, Inc. Nurse 01/2002 to 01/2004

Mechanicsville, Virginia

Specifications, Advocating for Patients with Insurance Companies, Answering Telephones

Applying Dressings Arranging Prescription Refills.

Basic Life Support (BLS) Completing Patient Records After Exams and Test Results.

Patient education Supplied by Doctors to Patients.

Front Desk, scheduling appointments, filing charts

Interview patients to obtain medical information and measure their vital signs, Weight and height.

Authorize drug refills and provide prescription information to pharmacies.

Record patients' medical history, vital statistics, or information such as test results in medical records

Prepare and administer medications as directed by a physician.

Explain treatment procedures, medications, diets, or physicians' instructions to patients.

Help physicians examine and treat patients, handing them instruments or materials or performing such tasks as giving injections or removing sutures.

Perform routine laboratory tests and sample analyses.

Change dressings on wounds.

Interbake Food FFV Cookie Company 08/1994 to 01/2002

Packing of Cookies and crackers on assembly line.

Assured quality product production

Training of other product line workers

Quality Assurance check of product prior to assembly

Machine engineer of cookie assembly lines

Stacking, palletizing and storage of products

Mentor and guide new workers

OSHA trained and compliance

Standing for 8-16 hours at a time

Lifting 5-25 pounds repeatedly

Education

University of California – Irvine Budgeting and Scheduling Projects July 2016

University of California – Irvine Initiating and Planning Projects July 2016

Bachelors of Science: Business Management July 2014

University of Phoenix - Richmond, VA

Associates Degree: Nursing Jan 2013

J Sergeant Reynolds Community College - Richmond, VA.

oGood Clinical Practice Training Polaris Compliance Consultant Group Jan 2016

oGood Clinical Practice Curriculum CITI Collaborative Institutional Training Initiative Jan 2015

oHealth Information Privacy and Security (HIPS) CITI Collaborative Institutional Training Initiative Jan 2015

oAcademy of Clinical Research Professionals Certified Clinical Research Coordinator 2014

oCurrent BLS-Basic Life Support for Healthcare Provider CPR/AED Course Heart Lights CPR/CPR Virginia Training Center: Jan 2014

oAffiliations

oG.I.R.L.S. Rule Mentoring Program

oRedress Society, Fighting Heart Disease in Woman

oNational Organization for the Advancement of Colored People

oRichmond Chapter (NAACP)

oNational Urban League

oClinical Research Study History

oCharacterization of Nicotine Exposure Profiles and Subjective Measures of Verve Chews Products for Abuse liability determination in Adult Smokers relative to Combustible Cigarettes and Nicotine Gum.

oA Characterization of Nicotine Exposure Profiles and Subjective Measures of Verve Disc Products for the abuse liability Determination in adult Smokers Relative to Combustible Cigarettes and Nicotine Gum.

oPilot Cross-sectional study to evaluate the exposure to tobacco smoke constituents

oAnd health status of adult exclusive e-vapor users and adult conventional cigarette

oSmokers Altria Client Services LLC 2016

oCharacterization of Nicotine Exposure profiles of NU MARK'SE-VAPOR products with

oShort term evaluation of the Abuse Liability in adult smokers Altria Client Services LLC

o2016

oProtecting Human Research Participants The National Institute of Health (NIH) Office

oA Randomized Controlled Cross-Over Study in Adult Moist Smokeless Tobacco (MST)

oUsers to quantify the amount of Nicotine, NNN, and NNK available for uptake from

oWintergreen flavored MST products (QUID STUDY) Altria Client Services LLC 2015

oA 3-Week Pilot Clinical Study to Evaluate Tobacco Product Use in Adult Smokers Who

oUse Electronic Cigarettes (MarkTen® or Prototypes), either ad libitum or with

oPre-Specified Daily Amount, or do not Use Electronic Cigarettes, While Smoking

oConventional Cigarettes ad libitum, Phase I/ Altria Client Services LLC 2015

oCharacterization of puff topography during 8-hour ad libitum use of markten® e-vapor

oProducts (2.5% nicotine by weight) in adult conventional cigarette smokers, cigarette

oAnd e-vapor dual users and exclusive e-vapor users, Phase I / Altria Client Services LLC 2015

oCharacterization of nicotine exposure profiles of e-vapor products in adult smokers,

oPhase I/ Altria Client Services LLC 2015

oA randomized, controlled, cross-over clinical study to characterize the nicotine

oPharmacokinetics, subjective effects, and participant's choices of two moist snuff

oTobacco (MST) products compared to combustible cigarettes and nicotine gum in adult

oSmokers that use MST. Phase I Altria Client Services LLC 2015

oCharacterization of nicotine exposure profile of prototype cigarettes with different

oMenthol levels in adult smokers, Phase I /Altria Client Services LLC 2015

oA Single-Blind, Randomized, Parallel-Group, Multi-Center Controlled Study to Evaluate

oChanges in Exposure to Cigarette Smoke Constituents in Adult Smokers Using Different

oMenthol Cigarette Prototypes in a Clinical Setting (Menthol Cigarette Short-Term

oExposure Study [MSTEP]) Phase I/ Altria Client Services LLC 2015

oA Randomized, Single-Blind, 4-Way Crossover, Multi-Center, Controlled Study to

oEvaluate Pharmacokinetics and Exposure of Methyl Salicylate in Adult Users of Moist

oSmokeless Tobacco (MST) Wintergreen Products in a Clinical Setting, Phase I / Altria

oClient Services LLC 2015

oA Randomized Double Blind, 56 week Placebo Controlled. Parallel group Multi center.

oPhase 3 Study to Evaluate the Efficacy and safety of 3 doses of XXX in patients with

oModerate to severe COPD with a history of Exacerbations. AstraZeneca Terranova

oStudy 2015

oA Randomized active controlled. Open label, 3 treatment arm, Parallel Group

oMulticenter study, Comparing the efficacy and Safety of Insulin Glargine Lixisenatide

oFixed Ratio combination to Insulin glargine alone and to Lixisenatide on top of Metformin

oIn Patients with type II diabetes Mellitus Sanofi 2014

oA Phase II, 12-week, double-blind, randomized, parallel group, multi-center,

oInternational trial to assess the effect on glycemic control of five doses of XXX versus

oPlacebo or open-label XXX in subjects with type 2 diabetes. HM-EXC-204 2014

oA Phase 3, Randomized, Double Blind, Placebo Controlled, 26 Week multicenter

oStudy with a 26- week extension to Evaluate Efficacy and Safety of XXX monotherapy

oIn the treatment Subjects with Type 2 diabetes mellitus and inadequate Glycemic Control

oDespite diet and Exercise. MK-8003/B1521022 2014

oA Randomized Double Blind, Placebo- controlled, Parallel- group, Multi-center, Phase 3

oStudy to Evaluate the Long term Safety of XXX for the Treatment of Opioid- induced

oConstipation in Subjects with Nonmalignant Chronic Pain Receiving Opioid Therapy

oShionogi INC 1326V9235 2013

oA Multicenter, Randomized, Double- Blind, Placebo- Controlled Phase 3 Study to

oEvaluate the Long Term Safety and Tolerability of XXX for the treatment of Opioid

oInduced Constipation in Adults Taking Opioid Therapy for non-Chronic- non-Cancer Pain.

oCubist Pharmaceuticals 594-**-**-****

oA Multi-centered, Randomized, Double- Blind Study to Evaluate the Safety,

oTolerability and Efficacy of the addition of XXX to subjects with Type 2 Diabetes Mellitus

oWho Have Inadequate Glycemic control on XXX Therapy .HM-EXC-203 2012

oA Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy

oAnd Safety of XXXX Compared to Placebo When Used in Combination with XXXX in

oSubjects with Hypertension and Type 2 Diabetes Merck 3102 2012

oA Safety and Efficacy Study of Inhaled XXXX Combination versus Inhaled XXXX in the

oTreatment of Adolescent and Adult Subjects with Asthma. TEVA 2012

oA 6-month safety and benefit study of inhaled XXXX combination versus inhaled XXXX in

oThe treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma. TEVA

o2012

oA Clinical Outcomes Study to Compare the Effect of XXXX Inhalation Powder XXXX

oMcg with Placebo on Survival in Subjects with Moderate Chronic Obstructive

oPulmonary Disease (COPD) and History of or at Increased Risk for Cardiovascular

oDisease Novartis Pharmaceutical CNVA237A2318 2012

oA Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Efficacy and Safety of XXXX Monotherapy Compared to Placebo in Subjects with Gout and an Intolerance or Contraindication to XXXX Ardea Biosciences RDEA-303

oA Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of XXXX and XXXX Compared to XXXX Alone in Subjects with Gout who have had an Inadequate Hypouricemic Response to Standard of Care XXXX Ardea Biosciences RDEA-301

oA Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination

oStudy to Evaluate the Efficacy and Safety of XXXX and XXXX Compared to XXXX Alone at

oLowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout. Ardea

oBiosciences RDEA-304 2012

oA Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess

oThe Efficacy and Safety of XXXX Monotherapy Compared to Placebo in Subjects with

oGout and an Intolerance or Contraindication to XXXX Ardea Biosciences RDEA-303 2012

oEvaluate Pharmacokinetics and Exposure of Methyl Salicylate in Adult Users of Moist

oSmokeless Tobacco (MST) Wintergreen Products in a Clinical Setting, Phase I / Altria

oClient Services LLC 2015

oA Randomized Double Blind, 56 week Placebo Controlled. Parallel group Multi center.

oPhase 3 Study to Evaluate the Efficacy and safety of 3 doses of XXX in patients with

oModerate to severe COPD with a history of Exacerbations. AstraZeneca Terranova

oStudy 2015

oA Randomized, Double-Blind, Placebo-controlled, Phase 3 Study to Evaluate the

oEfficacy, Safety, and Tolerability of XXXX in the Treatment of Patients with Diarrhea-

oPredominant Irritable Bowel Syndrome. 2012

oA multicenter, international, randomized, parallel group, double blind study to evaluate cardiovascular safety of XXXX versus XXXX In patients with type 2 diabetes mellitus at high cardiovascular risk. Merck/Pfizer 2012

oA Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled,

oParallel-group, Multicenter Trial of XXXX Controlled-release Tablets (XXXX) to Assess the

oAnalgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced

oConstipation (Compared to XXXX Controlled-release Tablets (XXXX) in Opioid-

oExperienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain

oAnd a History of Opioid-induced Constipation who Require Around-the-clock Opioid

oTherapy. Purdue 3704 and 3705 2012

oA Phase III Randomized Clinical Trail to Study the Efficacy and Safety of the

oCo-Administration of XXXX and XXXX in Patients with Type 2 Diabetes Mellitus with

oInadequate Glycemic Control on XXXX Monotherapy. 2012

o6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and

oSafety of a New Formulation of XXXX and XXXX both plus Mealtime Insulin in Patients with Type 2

oDiabetes Mellitus with a 6-month Safety Extension Period Sanofi EFC11928 2012

o6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the

oEfficacy and Safety of a New Formulation of XXXX and XXXX both in combination with

oOral antihyperglycemic drug(s) in Patients with Type 2 Diabetes Mellitus with a 6-month

oSafety Extension Period. Sanofi EFC11629 2012

o2012 Anemia / Renal Impairment

o2012 Rheumatoid Arthritis

o2012 650 DM Type II/ CV Event

o2012 IBS

o2010-2012 Dermatology

o2012 DM Type II / Renal Impairment

o2011 Observational Diabetes Type II Insulin Therapy

o2011 Phase III Diabetes/ Lipid

o2011 COPD/ CV Event

o2010-2011 cardiology

o2010-2012 Neurology

o2011 Gout/ CV Event

o2010 Phase III Gout with CV Disease

o2010 Gout/ CV Event

o2009 Phase III Pediatric Meningitis Vaccine

o2009 Phase IIIb Pediatric Meningitis Vaccine

o2008 Phase III COPD

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