Medical Safety
Resume:
CURRICULUM VITAE
ARISTOTOLES I. BALOBALO, CCRC
San Diego CA 92103
*********@***.***
EDUCATION
Naval School of Health Sciences 1995
San Diego, CA
Medical Laboratory Technician 91.3
Naval School of Health Science 1993
San Diego CA
US Navy Hospital Corpsman (LVN Equivalent)
Emilio Aguinaldo College(Undergrad) 1989
Manila, Philippines
BS Physical Therapy
PROFESSIONAL EXPERIENCE
PAREXEL International October 2011-Present
San Diego, CA
Clinical Trial Specialist
• Conducts feasibility, collects Confidentiality agreement and site pre-qualification activities.
• Involved in site selection activities such as, document collection, review and approval of investigator site regulatory package documents.
• Responsible in creating , reviewing and approving country and site specific ICFs. Assuring that the customized consents are in accordance to ICH, GCP’s and local regulatory agency guidelines and PAREXEL SOP’s prior to submissison to the regulatory authority/ethics committee.
• Act as a liason between sponsor, project leads and study site staff .
• Guides the study site staff to resolve contract or document issues and SRP-related queries status updates to appropriate team members.
• Ensures project tracking and CTMS is current and accurate to meet the project related timelines and contractual obligations and mentor and train new staff.
Accelovance September 2005-October 2011
San Diego, CA
Senior Clinical Research Coordinator
• Maintain a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test, procedures, laboratory information, and drug accountability requirements.
• Responsible for completion of all study documentation forms, including case report forms(ECRF and Paper CRF) and other study specific documents.
• Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the clinical protocol. Monitors participant's progress (e.g.; blood pressure, exercise, response to questionnaires, tracking, etc)
• Proficient in creating source documents, memory aids and study related material using Microsoft Programs.
• Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the clinical protocol.
• Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed, alerts Principal Investigator of serious adverse events.
• Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.
• Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols.
• Conducts clinical research in compliance with all applicable regulations
• Clean Driving Records and willing to travel upto 70 percent different facilities as needed.
Scripps Mercy Hospital 2005-Present
San Diego, CA
Laboratory Technical Partner
• Expert specimen collection and processing.
• Adhere to Standard of Procedure.
Naval Medical Center San Diego 2002-2004
San Diego, CA
Laboratory Administrative Assistant
Naval Medical Clinic Pearl Harbor 1999-2002
Pearl Harbor, HI
Medical Laboratory Technician
Naval Medical Center San Diego 1995-1999
San Diego, CA
Medical Laboratory Technician
CERTIFICATIONS
CPR Certified
California Certified Phlebotomy Technician
Certified Clinical Research Coordinator – ACRP 08 September 2007
IATA Certified
CITI Human Research Training
NIH Human Protection Certified
RESEARCH EXPERIENCE
A randomized, double-blind, placebo-controlled, force-titration, Phase IV study comparing XXXXX 80 mg + XXXXX 25 mg versus XXXXX 160 mg + XXXXX 25 mg taken orally for 8 weeks in patients with Stage 1 or Stage 2 hypertension.
A multicenter, partially blind, parallel-group, controlled study of the safety and immunogenicity of XXXXX vaccine compared with XXXXX in a healthy population Phase II Anthrax vaccine study.
A double-blind, randomized, placebo-and active-controlled, forced titration study evaluating the effects of XXXXX on blood pressure and heart rate in African American patients with hypertension.
Prospective, Observational Registry Study of the Management of Men with Symptomatic Benign Prostatic Hyperplasia (BPH): Observational Registry in BPH -- Intervention and Treatment Beta-Testing Phase.
A Multicenter, Randomized, Double-Blind, Prospective, Placebo-Controlled Study Comparing the Safety and Efficacy of XXXXX and FDA Approved Statin Combination Therapy to XXXXX and FDA Approved Monotherapy in Subjects with Mixed Dyslipidemia.
A randomized, double-blind, double-dummy, placebo-controlled 4x4 factorial design trial to evaluate XXXXX 20, 40 and 80 mg tablets in combination with XXXXX 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABPM sub -study.
A Phase 3 Study on analgesic efficacy and safety of HCT 3012: A Randomized Double-Blind 13-week placebo and XXXXX-Controlled , multicenter efficacy study of XXXXX (375 mg bid and 750 mg bid) in patients with osteoarthritis of the knee.
A Long-Term, Open-label, Safety Extension Study of the Combination of XXXXX and XXXXX therapy for Subjects with Mixed Dyslipidemia.
A phase IIIb, prospective, double-blind, randomized, controlled multicenter study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [XXXXX®] compared to Sanofi Pasteur's XXXXX, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [XXXXX®], when administered as a booster vaccination in adults aged 19 to 64 years of age.
Phase I/II, Randomized Study to Evaluate the Safety and Immunogenicity of Transcutaneous Trivalent Influenza Vaccination with Different Doses of Heat-Labile Enterotoxin of Escherichia coli in Healthy Adults.
A Placebo Controlled, Randomized, Double Blind Study to Compare Antioxidant Levels in Normal Subjects with Elevated Waist Circumference When Administered 1 or 2 XXXXX Dietary Supplement Capsules for 4 Weeks.
Multi-center, Randomized, Double-Blind, Randomized, Parallel group, Placebo-Controlled, study to investigate the safety and efficacy of an oral medication once daily, in preventing heartburn with a 1-week placebo-run-in period, and a 2-week placebo or study drug treatment period.
A Double-Blind, Randomized, Placebo Controlled Factorial Study to Evaluate the Efficacy and Safety of XXXXX and XXXXX Alone and in Combination in Subjects with Hypercholesterolemia.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of XXXXX (XXXXX) When Used in Combination with XXXXX in Subjects with Type 2 Diabetes.
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of XXXXX in Subjects with Mild to Moderate Uncomplicated Essential Hypertension.
A Multicenter, Randomized, double-Blind, parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of [XXXXXX] Versus XXXXX in Patients with Mixed Hyperlipidemia.
A Parallel randomized, open-label, multicenter study of [XXXXXX (375 mg bid and 750 mg bid)] in subjects with osteoarthritis of the knee (follow-up of the 13- week, double-blind, parallel, randomized, placebo- and Naproxen-Controlled XXXXX-X-301 efficacy and safety study.
A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of XXXXXX Concentrate (XXX Flu and Cold Formula) for the Prevention of Cold and Influenza.
A randomized, double-Blind Study Evaluating the Safety and Tolerability of a 600-mg QD Dose and a 600-mg BID Dose of Oral XXXXX Versus Oral Placebo for 14 Days in Volunteers.
A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Extended Cycle Oral Contraceptive Regimens (DR-1031) Compared to Seasonale Oral Contraceptive Regime.
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral dose Typhoid Fever Vaccine (XXXX) in Healthy Adult Subjects.
Gastrointestinal Randomized Event and Safety Open Label NSAID Study: A Randomized, Open-Label Blinded-Endpoint, Parallel-Group Trial of GI Safety of Celecoxib Compared wiuth Non-Selective Nonsteroidal Anti-inflammatory Drugs (NSAIDS) in Osteoarthritis Subjects.
A Randomized, Double-Blind, Placebo-Controlled,Crossover Clinical Trial to Evaluate the Safety and Efficacy of a Marketed Medical Food Containing GanedenXXX (bacillus coagulans) on Symptoms of Lactose Intolerance.
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenecity of Pandemic Influenza Plasmid DNA Vaccines.
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenecity of Pandemic Influenza Plasmid DNA Vaccines Administered with the Biojector® 2000 Needle-free System.
Audrey Project Consumer Focus Group Study.10/4 person focus groups to review a feminine care product.
A Randomized, Double-Blind, Placebo-Controled, Clinical Trial to Evaluate the Safety and Efficacy of a Marketed Medical Food Containing GanedenXXX (bacillus coagulans) on Symptoms of Diarrhea Predominant Irritable Bowel Syndrome.
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients with Moderate to Severe Atopic Dermatitis.
A prospective, multi-center, paired data, cohort screenibng rial comparing SCOUT DS to the fasting Plasma glucose Test in Subjects at Risk for Diabetes
A Phase II, Multicenter, Randomized, Observer-Blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL’s Novel Influenza A(H1N1) Vaccine XXXXX in Healthy Adults Aged 18 Years and Older
An Observer-Blinded, Randomized, Parallel-Group, Multi-center Study Comparing the Safety and Immunogenicity of XXXXXX™ to Licensed Vaccine (Engerix-B®) among Healthy Subjects 40 to 70 Years of Age”
A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Plasmid DNA Vaccine XXXXX Against Novel H1N1 Influenza Virus in Healthy Adults
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