Resume

Sign in

Clinical Research Manager

Location:
Oakland, California, 94607, United States
Posted:
December 11, 2018

Contact this candidate

Resume:

PRISCILA-GRACE SORIANO GONZAGA

*

PRISCILA-GRACE SORIANO GONZAGA

**** **** ****** *******, ** 94607 ac7xpg@r.postjobfree.com 510-***-**** CLINICAL RESEARCH MANAGER / CRC / CRA

Licensed Vocational Nurse (LVN) with 12+ years’ progressive experience as a Sr. Clinical Coordinator, Research Manager, and Research Associate in both Device and Pharmaceutical settings. Highlights: Focused on HIV research, working extensively on gene therapy initiatives for research for a cure. Lead Coordinator for US’s top HIV cure gene therapy studies, enrolling & infusing more subjects than anyone; awarded by GlaxoSmithKline (GSK) as highest summer enroller on Herpes vaccine study screening 1,000+ subjects, enrolling 400. Ensure superb clinical care & customer service, adroitly coordinate nursing process & patient care delivery, manage other nurses. Instrumental on the approval of Abbott Diabetes Continuous Glucose Monitoring Device (FDA approved 2018) Team player & leader. Implement protocols, standards of practice, rules / regulations. Expert in assessing & caring for physical & emotional needs of wide-ranging patient populations. Remain calm & focused in most urgent of circumstances. Personable with all patients and staff go out of the way to ensure their comfort. Naturally meticulous, never take shortcuts, continually prepared for all scenarios. SIGNATURE STRENGTHS

Clinical Research & Analysis Patient Evaluations Patient Relationship Management Staff Management

Creating Testing Protocols Partnering with Staff, Vendors & Physicians Research & Medical Documentation

Drafting & Presenting Reports Multitasking Project Management Study Set-up Government Compliance: HIPPA, OSHA, FDA, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee) Document Specialist

Strong Psychosocial Skills Well Organized

EDUCATION

AS, Nursing / LVN, Carrington College; San Leandro, CA July 2004 – Dec. 2005 Top Preceptorship. License Type: CA Licensed Vocational Nurse. License #: 223999. Student Vocational Nurse – Preceptorship, Kaiser Permanente; Daly City, CA 2005 CERTIFICATIONS

● Collaborative Institutional Training Initiative (CITI Program)

● IV / Blood Draw

● CPR / Basic Life Support

● ICAO TI 4.2 / CFR 49 Subpart H / IATA 1.5: Dangerous Goods

● ICH Good Clinical Practice

● Shipping of Category A, Infectious Substance Affecting Humans

● Category B, Biological Substance

● NIH: Protecting Human Research Participants

● Transporting Dangerous Goods

● Data Privacy Training

● Research Aspects of HIPPA

● Annual Bloodborne Pathogens

● Hazard Communication Awareness Training

● Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis PROFESSIONAL EXPERIENCE

Clinical Research Associate III, Full-Time, Abbott Diabetes; Alameda, CA 2016 – 2018 In house Coordinator, CRA of internal studies and external sites;

● Direct work with team of Engineers, Clinicians, QC, CRA’s, Data Management, and external sites in development of Abbott’s Continuous Glucose Monitoring Device, Freestyle Libre System devices and strips (FDA approved 2018)

● Experience developing protocols for and coordinating human testing of wearable devices

● Responsible for the overall operational execution of clinical studies on one or more clinical projects/programs;

● In house study coordinator and CRA of early phase studies prior to external testing

● Support Quality Control and works in conjunction with engineers with the development and testing of new sensor wears;

PRISCILA-GRACE SORIANO GONZAGA

2

● Manage external sites and study execution, including technical execution, budget and timeline, and ensure all regulatory and quality compliance requirements are met;

● Perform site monitoring visits (feasibility, SIV, IMV, Close-Out) and site management activities to assess the sites ability to effectively and continuously conduct the trial per the protocol, GCP, and regulatory requirements.

● Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects, including: a) Assists in the development of study related materials b) Review and approval of site informed consent document to ensure all required elements are included. c) In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.

d) Coordinates activities with study vendor services, and core labs. e) Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries. f) Reviews and processes product complaints and adverse events as soon as they are reported. Clinical Research Manager/ Sr. CRC, Full-Time, Quest Clinical Research; San Francisco, CA 2007 – present Manages site staff and clinical studies as well as Coordinate research on HIV, as well as HCV, HBV, and infectious diseases. For HIV cure gene therapy studies, enrolling & infusing more subjects than any other individual (CALIMMUNES CAL-USA- 11, and Sangamo’s SB-728-0902, 1002, 1101 and collaboration with City of Hope’s 14017). Previously focused on healthy women’s studies at first. HIV clinic affiliated with UCSF (now known as Quest Clinical Research, as of 1989). Manage eight

(8) coordinators one (1) lab manager and (2) secretary’s. Oversee all research and large patient population.

● Manages and creates site SOP’s, CAPA’s, Note to File’s, Sponsor Discrepancies, IRB submissions and other regulatory affairs.

● Manages and creates site source documents, sponsor specific source documents, office forms, trainings, and other office matters.

● Collaborate with patient subjects on phase I, II, & III efficacy of controlled drugs/vaccines (HPV, HIV, HSV, HCV, HBV).

● Supervise clinical trials; orchestrate patient care and administrative duties.

● Educate patients regarding proper procedures and information needed pre-trial: appointments, medications, personal care, medical history, current and past treatments, consenting process.

● Monitor patients for safety concerns and side effects. Prepare patients for procedures; conduct vitals, ECGs, blood draws, vaccinations, medication prescriptions, cervical exams, pap smears, STD and pregnancy testing, IV-line placement, daily venipunctures, lab value assessments. Counsel on diet and nutrition, performing wound care.

● Drug administration and accountability

● Assess patient health and safety on experimental medications by making in-home healthcare visits.

● Administer agents to HIV patients, monitor for adverse reactions.

● Lab processing of whole blood and serum, plus packing and shipping of serology / chemistry / virology materials. RESEARCH PROTOCOLS:

Lead coordinator / “blinded” pharmacist for the following clinical trials: Current studies:

Assembly’s ABI-H0731-201: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed HBeAg-positive Patients with Chronic Hepatitis B Assembly’s ABI-H0731-202: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B LaJolla’s LJ401-HH01: A Phase 2 multicenter, randomized, placebo controlled, double-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population Sangamo & City of Hope's 14017: A Pilot Study to Evaluate the Feasibility, Safety and Engraftment of Zinc Finger Nuclease

(ZFN) CCR5 Modified CD34+ Hematopoietic Stem/Progenitor Cells (SB-728mR-HSPC) in HIV-1 (R5) Infected Patients. TaiMed’s TMB-311: A monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of PRISCILA-GRACE SORIANO GONZAGA

3

intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection.

Intercept's 747-303: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis. Calimmune’s CAL-USA-11- An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning with Busulfan in HIV-1 Infected Adults Previously Exposed to ART. Sangamo’s SB-728mR-T- A Phase 1/2, Open-Label Study to Assess the Safety and Tolerability of Repeat Doses of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects Following Cyclophosphamide Conditioning.

Tobira’s CENTAUR- Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects with Liver Fibrosis.

Completed Studies:

GSK’s 208141/039- A double-blind, randomized, controlled Phase III study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are HSV-1 and -2 seronegative.

(Received an award for the highest enrollers for Summer of 2007.) GSK’s 580299-008- A phase III, double-blind, randomized, controlled, multi-center study to evaluate the efficacy of GlaxoSmithKline Biological HPV-16/19 vlp/as04 vaccine compared to hepatitis A vaccine as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6-month schedule in healthy females 15-25 years of age.

GSK’s 108933 (HPV 010)- A phase IIIb, observer-blind, randomized, multicenter study with two parallel groups to compare the immunogenicity of GlaxoSmithKline Biological’s HPV-16/18 L1/AS04 vaccine versus Merck’s Gardasil vaccine when administered intramuscularly according to a 3-dose schedule in healthy adult females 18-45 years of age. Merck’s V501/015-10- A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16-/18-Related CIN 2/3 or Worse of GARDASIL® (Human papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) in 16- to 23-Year-Old Women – The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease). Pharmassett’s CI-PSI-5268-06-305 & CI-PSI-5269-06-306 - A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus. Janssen-Cilag’s (formally Johnson & Johnson) OZ1-HV1-202- A long term follow-up protocol to evaluate the safety and survival of autologous CD34+ hematopoietic progenitor cells transduced with an anti-HIV-1 ribozyme (OZ1) in patients with HIV-1 infection.

F. Hoffmann-La Roche’s NV17590C- An open-label, multicenter protocol providing PEGylated interferon alfa-2a

(PEGASYS®) as monotherapy or in combination with ribavirin (COPEGUS®) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols. Pfizer’s A8121007- A phase 2, randomized. Placebo controlled, dose-ranging study to evaluate PEGINTERFERON ALFA-2A

(PEGASYS®) and RIBAVIRIN (COPEGUS®) with and without PF-00868554 in subjects chronically infected with Hepatitis C virus.

Taimed’s TMB-202- A Phase 2b, Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1. Myriad’s MPC-4326-003- A phase 2b multicenter, randomized, open-label, comparative trial of MPC-4326 in combination with a two- to three-drug optimized background regimen versus an optimized, three- to four-drug antiretroviral regimen for the treatment of triple-class antiretroviral-experienced, HIV-1-infected subjects failing current therapy. PRISCILA-GRACE SORIANO GONZAGA

4

Sangamo’s SB-728-0902- A Phase 1 Single and Repeat-Dosing Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 in HIV-Infected Subjects who have Exhibited Suboptimal CD4+ T-Cell Gains During Long-Term Antiretroviral Therapy.

GSK’s phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals herpes zoster vaccine, gE/AS01b in comparison to placebo when administered as 3 doses to adult HIV- infected subjects.

ViiV’s 201147- a Phase IIIb, Randomized, Open-label Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed- dose Combination of Abacavir/Dolutegravir/ Lamivudine from Current Antiretroviral Regimen Compared with Continuation of the Current Antiretroviral Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed, The STRIIVING Study. Genocea’s GEN-003- A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals with Documented Genital HSV-2 Genital Infection.

GlaxoSmithKline’s phase IIb, randomized, observer-blind, placebo controlled, multicenter primary/booster therapeutic vaccination study to determine efficacy and safety of F4co/AS01b vaccine, administered intramuscularly according to either a two dose (0, 4 weeks) or a three dose (0, 4, 28 weeks) schedule in ART-naïve HIV-1 infected persons aged 18-55 years. PER-DIEM POSITIONS

Nuclear Cardiology Nurse, Fulltime, Cardiovascular Associates; Burlingame, CA 2007 – 2007 Safety Nurse- Correctional Facility, California Medical Facility; Vacaville, Ca 2007 – 2007 Medical Records Reviewer, Part-time, Contract, Outcomes Inc., San Francisco, CA 2007 - 2007 Licensed Vocational Nurse, Aequor Health; Palo Alto, CA 2007 - 2009 Injection Clinic Coordinator, IntrimHealth, Dos Palos, CA 2006 – 2009 PUBLICATIONS & BIBLIOGRAPHY

“HIV Cure Is Closer as Patient's Full Recovery Inspires New Research,” Richard Knox. http://www.npr.org/blogs/health/2012/07/18/156988650/hiv-cure-is-closer-as-patients-full-recovery-inspires-new-research

“A Reporter’s Journey: Living with HIV,” Ed Walsh. http://www.edgeboston.com/news/aids/features//143794/a_reporter%E2%80%99s_journey:__living_with_hiv

“Helping to Find a Cure for AIDS,” Bill Strubbe.

http://www.poz.com/articles/Cure_AIDS_UCSF_2697_21953.shtml

“Sangamos HIV Study Slides Dr. L. Morales Borges of Arc 09.12.12.” http://www.slideshare.net/RHMBONCO/sangamos-hiv-study-slides-dr-1-morales-borges-of-arc-091212

“HIV pathogenesis and treatment: systems biology perspectives” by R.P. Sékaly (Port St. Lucie, FL). http://www.eradication2013.com/pages/repository/download/slide/sekaly.pdf

“Inflammation and Immunereconstitution: Interferons at the Crossroads.” www.anrs.fr/content/download/4808/26866/file/RP%20Sekaly.pdf

“HIV Cure.”

http://www.abc.net.au/catalyst/stories/3861455.htm TECHNOLOGY

MS Office (Excel, Word, PowerPoint, Access); MS Outlook; Mac & Windows Environments; Adobe Acrobat, Sasi-XP, Internet research, RDE, Syreon, Impala, Citrix, ClinTrak, Viedoc, Intralinks, Adamas, Oracle, En@ble, OpenClinica, Bioclinica, CT Engine, Sudova, Cenduit, Clinone, Bracket, Firecrest, Medidata, Hercules FOREIGN LANGUAGES

PRISCILA-GRACE SORIANO GONZAGA

5

Native Tagalog, Fluent English



Contact this candidate