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Clinical Research Quality Control

Location:
Miami, Florida, United States
Posted:
October 20, 2016

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October **, ****

Luis A. Pérez

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

Miami, FL. 33187

Dear Sir or Madam:

My experience as well as my interest in furthering my career in the field of Clinical Research have urged me to send you this letter (including attached CV).

I have a solid background supervising and administering project related activities in the field of clinical research, and contract management. My experience encompasses disciplines that include but are not limited to, compliance monitoring, quality control reviews, source preparation, subject recruiting, medical records review, subject consent, subject visits (clinical and documenting), SAE documentation, and EDC/IVRS documentation. Contractual projects were often in the multi-million dollar range, requiring knowledge, collaborations, and the application of tools and techniques critical to a successful outcome. Some of my successful collaborations have involved academic institutions and governmental agencies like: The University of Miami/Department of Pediatrics, Jackson Memorial Hospital Mental Health, and South Miami Hospital Child Development Center, to name a few. Some of the healthcare programs I collaborated with included: UM Adolescent/Young Adult, UM Hematology/Oncology, UM Liver/GI, UM Genetics, UM Sickle Cell, and SMH Child Development Center to name a few.

In addition to my professional experiences I hold an MBA and BS degree from Nova Southeastern University (NSU). I successfully completed the first year of my nursing program and will be sitting for my LPN boards this upcoming May. I am also preparing for the CCRP certification. Lastly, I plan on returning to school to complete my RN degree (online) this spring.

The administrative and technical experience I have received on the field and in the classroom have created an excellent balance that I am sure you will find mutually beneficial. I would very much like to put my skills to work for your organization. I look forward to the opportunity to interview and further discussing my qualifications with you.

Thank you for your consideration.

Respectfully,

Luis A Perez (Alex)

Synopsis of Relevant Professional Experience

Specific for the Clinical Research Field:

10+ Years - Field Health Care

9 Years - Contract Management

8 Years - Project Management

8 Years - Monitoring Programmatic (Regulatory) and Fiscal Contracts

7 Years - Negotiating, Writing, and Managing Health/Medical Contracts

7 Years - Instructor/Trainer

2+ Years - Clinical Research (Quality Control & CRC)

CURRICULUM VITAE

Luis A. Perez

14867 SW 177 Terrace

Miami, FL. 33187

305-***-****

LANGUAGE:

English & Spanish

EDUCATION:

2016: Excelsior College

Miami, Florida

College of Nursing (Online Commence 12/2016)

2014: Mercy Hospital School of Nursing

Miami, Florida

Practical Nursing (Board Eligible - 9/2016)

2008: Florida International University

Miami, Florida

Master of Adult Education/HRD (12 credits remaining)

2007: Nova Southeastern University

Miami, Florida

Master of International Business Administration

2003: Nova Southeastern University

Miami, Florida

Bachelor of Science, Professional Management

PROFESSIONAL EXPERIENCE:

9/2016 – Medeye Associates

Miami, FL 33183

Clinical Research Coordinator

Liaise with research department director in the development of phase I trials for optometry studies; Review, and screen target participants for phase 2 and 3 optometry trials (including surgery); maintain and update internal database; secure an informed consent of all the participants; comply with IRB guidelines; collect accurate subject information and data; ensure and timely documentation of source document (SD), EDC/IVRS throughout study duration; responsible for the proper preparation and distribution medications; ensure regulatory binder is maintained throughout course study, ensure appropriate and up to date documentation e.g. regulatory, SD, and EDC in anticipation of sponsor compliance monitoring activities; document A/E and SAE's as necessary; ensure compliance with corporate metrics and other related duties.

5/2014 – 6/2016 International Research Associates

Miami, FL 33183

Clinical Research Coordinator/Recruiter

Search, screen and signing-up of the target participants; maintain and update CTMS database; secure an informed consent of all the participants; comply with IRB guidelines; collect accurate subject information and data; ensure proper and timely documentation of source document (SD), EDC/IVRS throughout study duration; responsible for the proper preparation and distribution medications; ensure regulatory binder is maintained throughout course study, ensure appropriate and up to date documentation e.g. regulatory, SD, and EDC in anticipation of sponsor compliance monitoring activities; document A/E and SAE's as necessary; ensure compliance with corporate metrics and other related duties.

3/2015–7/2015 Actavis/Allergan (Temporary Assignment)

Miramar, FL 33331

Quality Control Associate

Review, plan and prepare study submission documents per CRF guidelines ; ensure technical accuracy of data entered by lab technicians; clinical support, nurse and paramedic staff members; ensure compliance to institutional and federal applicable regulatory and quality policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) guidelines for all research programs; comply with department establish metrics; and other related duties.

4/2013–4/2014: Mercy School of Nursing

Miami, FL 33317

Nursing Student

2/2011 –2/2013: Baptist Hospital

Miami, Florida 33176

Corporate Contracts Administrator/ Imaging Tech Asst.

Image Tech (P/T while attending school)

Assist the CT, Ultra Sound, X-Ray and MRI Techs with pick up and drop off of

patients; prepare CT patients for scans by placing them correctly on the scanner

and prepping them for contrast as required; document patient pick up and drop off;

ensure doctor's orders match the information contained in patient chart and that

all required signatures are obtained prior to examination; authenticate all patient

information (name, dob) with patient prior to examination.

Corporate Contract Administrator

Manage cost centers (budgets, negotiation, rates agreements) for Information Technology (Hardware Group), Security, Emergency Response, Environmental Services and Consulting departments; review new and expiring contracts for potential cost saving opportunities and language; process purchase orders for executed agreement; develop and execute amendments as required for language changes and/or contract extensions.

8/2008 –8/2011: Miami Dade County Public Schools - P/T - Adult Education

Miami, Florida

Business Technology, ESOL/VESOL, Trainer

5/2008 –8/2008: Florida International University

Miami, Florida

Applications Support Group (ASG) Project Manager/Trainer

Interact with FIU College of Business (COB) users on a daily basis as required, provide user support for approved CRM applications; Develop training programs (intranet, web based or lecture) for new COB approved software; and other related duties.

10/2005 –8/2010: Miami Dade County Public Schools - P/T - Adult Education

Miami, Florida

Business Technology, ESOL/VESOL, Trainer

12/2006 –9/2007: FASTTRAIN Corp - F/T - Adult Technology Education

Miami, Florida

A+ (computer Hardware/Software and Applications), Network + (Fundamentals of Networking)Instructor

4/2004 –3/2006: L-3 Communications

Miami, Florida (Miami International Airport)

Site Supervisor/Lead Technician

In accordance with prescribed contract, organized and administered the day-to-day

operations of Miami International Airport (MIA) for L-3 and the TSA providing

support to regional customers by installing, troubleshooting, and maintaining

X-Ray and CT based security systems; directed and developed a team of

eight (8) technicians ensuring real time (24/7) coverage for technical support

matters; interfaced and coordinated with internal groups (Corporate) and customer

(TSA/Miami-Dade County) Project Teams for all MIA installation, and upgrades

as well as maintenance audits; provided on-site technical and operator training to

TSA operators and administration; developed KPI’s for MIA support staff,

maintained top regional scores by providing quality service, maintenance, and

excellent response times to service calls.

6/2003 –4/2004: Miami-Dade County - Homeless Trust

Miami, Florida

Contract Officer

Reviewed and analyze proposed contracts, Federal and State grants, and Professional

Service Agreements; monitored service providers for regulatory (programmatic) and

fiscal compliance, follow up with corrective action reports; provided assistance to

agencies and/or subcontractors in complying with State and Federal guidelines and

procedures related to fiscal management, budgets and contracts; Maintained contractual

budgets; conducted budgetary reconciliation exercises with providers as required;

Conducted a Surplus/Deficit analysis for end of fiscal year budgetary projections;

reviewed contracts, grants, and professional service agreements for compliance.

participated in Request for Proposal (RFP), Invitation to Bid (ITB) selection committees.

developed fiscal reports as requested by management.

10/1999 –3/2001: Florida Department of Transportation - Office of Information Systems (OIS)

Miami, Florida

Data Processing III - Network Technician/Desktop Support

Provided day-to-day level I, II desktop support and troubleshooting assistance to 750 workstations district wide (Miami-Dade and Monroe Counties); supported Novell (client), Windows 9X, NT platforms including all pertinent and applicable software for each respective department; assisted in the deployment of Lotus Notes R5 rollout;

provided assistance to the network administrator in monitoring daily networking

activity on a 100 Megabyte switched Ethernet network, assisted in the coordination

and deployment of all PC replacements and software installation/upgrades.

3/1994 –2/1999: Florida Department of Health (HRS) - Contract Administration Department

3/2001 –6/2003: Miami, Florida

Contract's Manager/Operations Management Consultant (OMCI)

Reviewed proposals (RFP’s, Budget); negotiated and prepared contractual agreements

between the department and service providers; managed multi-million dollar contractual obligations; conducted surplus/deficit analysis as required; monitored service providers for regulatory (programmatic) and fiscal compliance, follow up with corrective action reports; project manager for the DCF Contract Administrator on all new contractual Project

Assignments (Purchase/OCO).

MILITARY EXPERIENCE:

United States Marine Corps - 12/1989 - 2/1993

CERTIFICATIONS:

CCRP - In Progress

CITI – Certification in Bioethics 2015

NIH - Protecting Human Research Participants”. – 2014

NIH - GCP”. - 2016

Medidata – Certification 2015

MEDPACE EDC - 2015

Pfizer Firecrest - 2015

Phlebotomy – Certification 2014

CPR - Certified 2013

M-DCPS - Certification in Business Education

TRAINING:

CITI: Bioethics - 2015

National Institute of Health (NIH) “Protecting Human Research Participants”. - 2014

IATA - 2014

RealTime Clinical Trial Management System (CTMS)

RESEARCH:

Research Coordinator Projects (Diabetes, Osteoarthritis, Cholesterol, Obesity, COPD, among others):

2016 TEVA - Clinical Research Coordinator - A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOPICALLY APPLIED TV-45070 (4% AND 8% W/W OINTMENT) IN PATIENTS WITH POSTHERPETIC NEURALGIA.

2016 Pfizer - Clinical Research Coordinator - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

2015 Sanofi – Clinical Research Coordinator - A RANDOMIZED, OPEN LABEL, 2-ARM PARALLEL GROUP, MULTICENTER, 26 WEEK STUDY ASSESSING THE SAFETY AND EFFICACY OF HOE901-U300 VERSUS LANTUS IN OLDER PATIENTS WITH TYPE 2 DIABETES INADQUATELY CONTROLLED ON ANTIDIABETIC REGIMENS EITHER INCLUDING NO INSULIN, OR WITH BASAL INSULIN AS THERE ONLY INSULIN.

2015 Novo Nordisk – Clinical Research Coordinator - A TRIAL COMPARING CARDIOVASCULAR SAFETY OF INSULIN DEGLUDEC VERSUS INSULIN GLARGINE IN SUBJECTS WITH DIABETES TYPE 2 DIABETES AT HIGH RISK OF CARDIOVASCULAR EVENTS.

2015 Evoke Pharma – Clinical Research Coordinator - A MULICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP CLINICAL STUDY TO EVELUATE THE EFFICACY AND SAFETY OF METOCLOPRAMIDE NASAL SPRAY IN MEN WITH SYMPTOMS ASSCIATED WITH GASTROPARESIS.

2015 Rhythm Pharmaceuticals - Clinical Research Coordinator - A PHASE 2-B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, STUDY TO EVALUATE TH SAFEY AND EFFICACY OF RM-131 ADMINISTERED TO PATIENTS WITH VOMITING EPISODES AND MODERATE TO SEVERE DIABETIC GASTROPARESIS

2015 Elcelyx - Clinical Research Coordinator - A RANDOMIZED, DOUBLE-BLIND, PARALLEL- GROUP, MULTICENTER, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE GLYCEMIC EFFECTS, SAFETY AND TOLERABILITY OF METFORMIN DELAYED- RELEASE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS

2015 Novo Nordisk – Clinical Research Coordinator - DOSE-FINDING OF SEMAGLUTIDE ADMINISTERED SUBCUTENEOUSLY ONCE DAILY VERSUS PLACEBO AND LIRAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES

2014 Pfizer - Clinical Research Coordinator - PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-04950615, IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS Compound: PF-04950615

2014 Forest Research Institute - Clinical Research Coordinator - DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, PHASE IV STUDY TO EVALUATE THE EFFECT OF ACLIDINIUM BROMIDE ON LONG TERM CARDIOVASCULAR SAFETY AND COPD EXACERBATIONS IN PATIENTS WITH MODERATE TO SEVERE COPD (ASCENT COPD).

Quality Control Projects:

2015 Quality Control Associate - An open labeled, randomized, single dose, two way crossover bioequivalence study of two tablets of Conjugated Estrogen/Bazedoxifene, 0.45 mg/20 mg in healthy, adult, human, postmenopausal female subjects under fasting conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, two way crossover bioequivalence study of two tablets of Conjugated Estrogen/Bazedoxifene, 0.45 mg/20 mg in healthy, adult, human, postmenopausal female subjects under fed conditions.

2015 Quality Control Associate - An open labeled, randomized, two treatment, two period, two sequence, single dose crossover bioequivalence study of Carbidopa/ Levodopa extended release capsules, 61.25 mg/245 mg in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate - An open labeled, randomized, two treatment, two period, two sequence, single dose crossover bioequivalence study of Carbidopa/ Levodopa extended release capsules, 61.25 mg/245 mg in healthy, adult, human subjects under fed conditions.

2015 Quality Control Associate -. An open labeled, randomized, single dose, three-way crossover bioequivalence study of Aprepitant powder for suspension, 125 mg/ 5 mL in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate -. An open labeled, randomized, single dose, three-way crossover bioequivalence study of Aprepitant powder for suspension, 125 mg/ 5 mL in healthy, adult, human subjects under fed conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, three way crossover relative bioavailability study of Oxycodone extended release Tamper Resistant Capsules, CII, 40 mg in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, three way crossover relative bioavailability study of Oxycodone extended release Tamper Resistant Capsules, CII, 40 mg in healthy, adult, human subjects under fed conditions.

2015 Quality Control Associate - A double blinded, randomized, single dose, three way crossover bioequivalence study of Erlotinib tablets, 150 mg in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, two-way crossover bioequivalence study of vaginal ring delivering 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinylestradiol in healthy, adult, human female subjects.

2015 Quality Control Associate - An open labeled, randomized, single dose, three-way crossover bioequivalence study of Methylphenidate hydrochloride extended release chewable tablets, 40 mg, CII in healthy, adult, human subjects.

2015 Quality Control Associate - An open labeled, randomized, single dose, three-way crossover bioequivalence study of Hydrocodone Bitartrate ER TR tablets, 20 mg in healthy, adult, human subjects under fed conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, two way crossover bioequivalence study of Fluticasone propionate inhalation aerosol, 2 x 110 mcg (2 actuations) (total dose of 220 mcg) in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate - A double blinded, randomized, single dose, three-way crossover bioequivalence study of fixed dose combination of Paracetamol and Diphenhydramine hydrochloride, 500 mg/ 25 mg IR film coated tablets in healthy, adult, human subjects under fasting conditions.

2015 Quality Control Associate - An open labeled, randomized, single dose, three-way crossover relative bioavailability study of Amantadine HCl extended release tablets, 340 mg in healthy, adult, human subjects under fasting conditions.

**As well several new Optimology projects (Phases 1, 2 and 3)**

List Of References

Marlene Rivera

Manager, Clinical Support

3400 Enterprise Way

Miramar, Florida 33025

Office 954-***-****

Fax # 954-***-****

Direct Ext. # 1441111

Direct Office # 954-***-****

Cell 954-***-****

acw5wr@r.postjobfree.com

www. Actavis.com

Carol Wagner

Senior Clinical Research Associate, CCRA

Novo Nordisk

Remote CRA

Miami, Florida

305-***-**** Office/Cell

acw5wr@r.postjobfree.com

Radu Cristea, MD, PhD

Sr. Clinical Site Manager

RPS Strategic Solutions

A Division of PRA International

On Assignment with Sanofi CSU

Office: 239-***-****

Cell: 239-***-****

e-mail: acw5wr@r.postjobfree.com



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