Clinical Research Medical Assistant
Resume:
Hilda Gonzaba, Sr. CRA
Irving, Texas 75038
adad62@r.postjobfree.com
TP-HR-WW-002-05 CV Version Date: 13 Oct 18
Effective Date: 26 Jun 18 Hilda Gonzaba
Related to: SOP-HR-WW-001 Page 1 of 3
CURRICULUM VITAE
NAME: Hilda Gonzaba
JOB TITLE: Sr. Clinical Research Associate
SUMMARY OF EXPERIENCE:
Over 16 years of experience as a Clinical Research Associate for Phase II-IV trials in various therapeutic areas, including, but not limited to: mental disorders, endocrinology, musculoskeletal, hypertension, oncology, cardiology, respiratory, gastroenterology, central nervous system, ophthalmology and ophthalmology device trials, dermatology, and women’s health. Worked as research coordinator for 5 years in a dermatologist office working in clinic as surgical assistant to dermatologist along with research coordinator duties. Worked on Acne Vulgaris, Eczema (Atopic Dermatitis) Psoriasis. Worked as coordinator in psychiatrist’s office focusing on Major depression trials, schizophrenia, bipolar disorder, Sleep disorders and Alzheimer’s. Clinical trial Mankind monitored clinical trial sites conducting trial for the treatment of type 2 diabetes mellitus (T2DM) has focused on correcting hyperglycemia, accompanied by other conditions and risk factors, including hypertension, overweight/obesity, and dyslipidemia, that affect morbidity and mortality. A broader view toward treating the array of physiologic derangements may provide significant long-term outcomes benefits. Significant EDC knowledge in OC-RDC, Inform, and Medidata Rave. Proficient in Spanish. PROFESSIONAL EXPERIENCE:
Contract Sr. Clinical Research Associate, Gonzaba Consulting, LLC Dallas-Texas, Pain Therapeutics, Aerotek Scientific, Catalyst Research, Aimmune Therapeutics, Auven Therapeutics, Green Key Resources, Parexel, ICON Research, TKL Research Specialty Dermatology CRO
September 2014 - Present
• Implement and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
• Assess the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Review and verify accuracy of clinical trial data collected, either onsite or remotely
• Provide regular site status information to team members, trial management, and updates trial management tools
Hilda Gonzaba, Sr. CRA
3618 Block Dr. Apt 1305
Irving, Texas 75038
adad62@r.postjobfree.com
TP-HR-WW-002-05 CV Version Date: 13 Oct 18
Effective Date: 26 Jun 18 Hilda Gonzaba
Related to: SOP-HR-WW-001 Page 2 of 3
Contract Sr. Clinical Research Associate, Clinical Research Management Group, Agawam, MA October 2013 – October 2014
• Conducted the clinical monitoring aspect of designated projects-Flexion Therapeutics, osteoarthritis of the knee, injection of triamcinolone acetonide extended release microsphere technology.
• Performed clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
• Collected regulatory documentation
• Performed qualification, initiation, monitoring and termination of investigational sites Independent Clinical Research Consultant/Sr. Clinical Research Associate, Irving, TX April 2001 – October 2013
• Independently contracted as a CRA for several clients, including, but not limited to: PPD, i3, TAB Clinical, PRC Clinical, Eli Lilly, Chiltren, ICON, RPS, Novartis, Quintiles, Covance, Alcon, Schering Plough, Neovista, University Hills Clinical Research, Execupharm, and Pharm-Olam, VetPharm, Inc.
• Monitored and managed investigative sites (pre-study, initiation, routine and close-out visits) for GCP compliance according to Sponsor and or client
• Reviewed electronic case report forms for completeness and conformity to available source documentation and adherence to protocol requirements.
• Resolved electronic CRF discrepancies and/or clarifications via site visit, telephone or fax as deemed appropriate for the study
• Performed investigational product accountability and reconciliation.
• Generated study specific documentation including monitoring trip reports, telephone contact reports, site correspondence, query resolution and expense reports.
• Assisted in preparation of and attend investigator meetings.
• Train and mentor new CRAs.
• Monitoring of Animal Trials:
• A 2-part study for Feline pain management associated with surgery
• An Equine study for Synovitis/Osteoarthritis
• A study for Hyperthyroid in Cats
• A study on hypothyroid in dogs,
• A study on osteoarthritis in Dogs
• A nutritional study for Cats
EDUCATION:
The University of Texas at Dallas, TX, BA in Interdisciplinary Studies- South West School of Medical Assistants, San Antonio, TX, 1977 American Medical Technologist received- Registered Medical Assistant, 1978 Hilda Gonzaba, Sr. CRA
3618 Block Dr. Apt 1305
Irving, Texas 75038
adad62@r.postjobfree.com
TP-HR-WW-002-05 CV Version Date: 13 Oct 18
Effective Date: 26 Jun 18 Hilda Gonzaba
Related to: SOP-HR-WW-001 Page 3 of 3
LANGUAGE SKILLS:
English: fluent; Spanish: proficient
PROFESSIONAL ASSOCIATIONS:
Association of Clinical Research Professionals
10/22/2018
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