MARCELA E. SILVA
Summary
Focused clinical research management professional recognized for high productivity and efficient task completion. Proficient in patient recruitment, regulatory compliance, and data analysis. Effective communicator and problem-solver, contributing to successful project outcomes.
Overview
20
20
years of professional experience
Work History
Clinical Research Coordinator / Psychometrist
Henry M. Jackson Foundation-Naval Medical Center San Diego
03.2017 - 10.2025
- Company Overview: Multi-site, longitudinal neuro-HIV study examining neurocognitive functioning in HIV-positive active duty service members. PI/AI: Brian Agan, MD; LCDR Derek Larson, MD.
- Manage all aspects of the study; including Periodically review and revise existing SOPs to reflect current study protocols, institutional policies, and regulatory guidelinesdesigning/updating source documents, protocol, and MOPs. ensure accurate documentation, study records, data management, assess and report adverse events
- Recruited, screened, interviewed, and obtained informed consent from participants.
- Administer and score neuropsychological evaluations following training with NIH neuropsychologists. Design and conduct training on neuro evaluations for new research staff.
- Abstract data from subjects' medical records and transcribe data in eCRFs; train fellow staff on chart abstraction and data entry.
- Coordinate study visits including the scheduling of study procedures such as labs, MRIs, and lumbar punctures.
- Draw blood and prepare lab specimens for shipment following IATA guidelines.
- Establish and maintain an effective network with physicians, hospital staff, and branch clinics.
- Prepare for outside monitoring visits by reviewing CRFs, source docs, regulatory files, adverse event logs, specimen storage, manuals, and training records.
- Multi-site, longitudinal neuro-HIV study examining neurocognitive functioning in HIV-positive active duty service members. PI/AI: Brian Agan, MD; LCDR Derek Larson, MD.
Research Study Coordinator / Bilingual Psychometrist
University of Texas Health San Antonio
05.2014 - 01.2016
- Company Overview: Randomized, double-blind, placebo-controlled, phase 3 trial of Tadalafil for Duchenne Muscular Dystrophy - Eli Lilly Clinical Trials. PI: Ratna Bhavaraju-Sanka, MD.
- Coordinate study visits: schedule study tests (MRI, EEG, Labs, etc.), accommodate out-of-town subjects, and prepare necessary accounting documents for departmental compliance and subject reimbursement.
- Provide study status updates to team members, including interaction to resolve site issues and facilitate timelines.
- Ensure that data entry remained current per SOP and maintained source and regulatory files.
- Coordinate sponsor and monitoring visits. Identify site issues and initiated correction plans based on monitoring report.
- Monitor subject safety and AE reporting to sponsor and IRB.
- Dispense and account for study drug and documented drug compliance.
- Randomized, double-blind, placebo-controlled, phase 3 trial of Tadalafil for Duchenne Muscular Dystrophy - Eli Lilly Clinical Trials. PI: Ratna Bhavaraju-Sanka, MD.
Research Project Coordinator
Texas Tech University Health Science Center
01.2007 - 10.2010
- Company Overview: Project FRONTIER (Facing Rural Obstacles to healthcare Now Through Intervention, Education & Research) PI: Sid O'Bryant, PhD.
- Work closely with the PI on all aspects of the study. Assist in the development and implementation of the study's protocol including drafting study manual, creation of study source documents, logs, and recruitment material (both in English and Spanish).
- Train study's personnel in research protocols, recruitment, and data entry. Train and supervise community recruiters. Supervise and train lab technicians/students on research protocol and Phase I data entry, quality assurance and quality control.
- Conduct participant interviews, and administer and score standardized neuropsychological evaluations both in English and Spanish.
- Responsible for clinical tasks such as taking and recording vital signs, height, weight and abdominal measurements, BMI, glucose level and blood oxygen saturation.
- Coordinate community outreach activities, consisting of educational presentations, community engagement events, build and maintain good rapport with project participants, and assist the study's Community Advisory Committee.
- Procurement of safety protocols for handling/transporting human blood.
- Project FRONTIER (Facing Rural Obstacles to healthcare Now Through Intervention, Education & Research) PI: Sid O'Bryant, PhD.
Psychometrist / Cognitive Rehabilitation Trainer
Texas Tech University Health Science Center
06.2005 - 12.2006
- Company Overview: Department of Neuropsychiatry and Behavioral Sciences. The Memory Disorders Clinic.
- Conduct neuropsychological evaluations on a variety of adult patients of the Memory Disorders Clinic. The clinic offered a comprehensive, interdisciplinary approach to diagnosing and managing Alzheimer's disease and other dementias (MS, VD, TBI, etc).
- Administer neuropsychological instruments, score test results, report results/behavioral observations, and update MDC patient neuropsychological information database.
- Conduct neuropsychological examinations as part of ongoing clinical research study for TTUHSC site of the Texas Alzheimer's Research Consortium (TARC).
- Participate in Consensus Diagnosis meetings. Interpret and translate for specialists during interviews and neurological assessments conducted on Spanish-speaking patients.
- Assist in the development and pilot processes of The Memory Shoppe, a non-medicinal memory enhancement outreach program. Coordinate and conduct cognitive assessments, client interviews and supervised cognitive rehabilitation therapy sessions.
- Educate patients/clients and family members in the management of Alzheimer's disease and other dementias.
- Conduct presentations on Maintaining a Healthy Brain/Cognitive Training Exercises/Management of Alzheimer's Disease and Caregiver Support at various community centers, clinics, and senior centers. Collaborated with the Garrison Institute on Aging and the Alzheimer's Association - West Texas Chapter.
- Department of Neuropsychiatry and Behavioral Sciences. The Memory Disorders Clinic.
Education
Pre-Medical Minor: Chemistry I & II, Organic Chemistry, A&P I & II, Microbiology
Houston Community College
01.2014
BA - Psychology & Spanish
Texas Tech University
01.2005
AAS - Computer Information Systems
Southwest Texas College
01.2002
Skills
- Clinical Trial Management
- Neuropsychological Test Administration
- Phlebotomy
- Community Outreach
- IRB Management
- Regulatory Compliance: GCP, HIPAA, FDA, DOT/AITA
- Medical & Scientific Knowledge
- AHA BLS CPR Certification
- Software Proficiency: Microsoft Office, Smartsheet, Medidata Rave, REDCap, EPIC, MHS Genesis
Publications
- The Cochran County Aging Study: Methodology and Descriptive Statistics, O'Bryant, S.E., Zhang, Y., Owen, D., Cherry, B., Ramirez, V., Silva, M.E., Hudson, C., Hobson, V., Grammas, P., Schiffer, R.B., Manning, G., Schrimsher, G.W., Lucas, J.A., Sutker, P.B., Texas Public Health Journal, 61, 1, 5-7, 2009
- An Evaluation of MMSE-Adjusted Scores Among Rural-Dwelling Mexican American Elders: The Cochran County Aging Study (CCAS), Humphreys, J. D., Silva, M.E., Hobson, V. L., Schrimsher, G., Zhang, Y., & O'Bryant, S. E., Poster session presented at the annual meeting of the National Academy of Neuropsychology, New York City, NY, 2008, October, Archives of Clinical Neuropsychology, 23, 6, 678-679
- An exploration into the Relationship between alcohol and tobacco usage and mental status in a rural Hispanic community, Zhang, Y., O'Bryant, S.E., Humphreys, J., Silva, M.E., Poster presentation at the American Academy of Health Behavior annual conference, Oxnard, CA, 2008
Languages
Spanish
Professional
References
References available upon request.
Timeline
Clinical Research Coordinator / Psychometrist
Henry M. Jackson Foundation-Naval Medical Center San Diego
03.2017 - 10.2025
Research Study Coordinator / Bilingual Psychometrist
University of Texas Health San Antonio
05.2014 - 01.2016
Research Project Coordinator
Texas Tech University Health Science Center
01.2007 - 10.2010
Psychometrist / Cognitive Rehabilitation Trainer
Texas Tech University Health Science Center
06.2005 - 12.2006
Pre-Medical Minor: Chemistry I & II, Organic Chemistry, A&P I & II, Microbiology
Houston Community College
BA - Psychology & Spanish
Texas Tech University
AAS - Computer Information Systems
Southwest Texas College