Study Operations Project Manager

• Mar 2022 - Present

Clinical Researcher

• Apr 2021 - Mar 2022

Clinical Trial Manager

• Dec 2019 - Dec 2020

Clinical Trial Associate via Crowdstaffinng

• May 2019 - Dec 2019

• Recruit, schedule, consent clinical study subjects and support Clinical Operations team members with study-related duties as necessary Minimum • Assist in the preparation, handling, distribution, filing, and archiving of clinical study documentation, including but not limited to, the completion, tracking, and management of Case Report Forms (CRFs), data queries, and clinical data flow • Support the preparation, handling, tracking, and distribution of Clinical Trial Supplies, as well as, accurately maintain Trial Master File documentation to ensure audit readiness for monitoring visits and resolve monitoring findings Show less

Clinical Project Manager

• Apr 2018 - Dec 2018

• Enlisted, maintained, and assured protocol compliance for all study participants in clinical trials and screened potential participants for protocol eligibility as well as participate in the informed consent process • Ensured research quality by practicing in compliance with standard operating procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations • Coordinated patient care in compliance with protocol requirements including but not limited to dispensing investigational drug, providing participants education regarding medication administration, and maintaining investigational drug accountability • Reviewed study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document all findings • Maintained consent forms, case report forms, serious adverse events and source documents to ensure that research is being conducted according to guidelines Show less

Lead Clinical Research Coordinator

• Sep 2012 - Apr 2018

• Designed, maintained, and validated study databases (eCRF), IRB protocols, consent forms, and SOP specific to each ongoing study • Obtained informed consents from parents of eligible infants admitted to well-baby, special care, intermediate, and neonatal intensive care units for studies focusing on: evaluating and validating new point-of-care devices for measuring bilirubin binding capacity, glucose-6-phosphate dehydrogenase (G6PD) enzyme activity, or end-tidal carbon monoxide levels; investigating the effects of kangaroo mother care on neurosteriod production; and assessment of the feasibility of using cycled phototherapy for treating newborn jaundice • Performed bench-top reference micro-assays for unbound bilirubin (peroxidase method), carboxyhemoglobin (microcapillary method by gas chromatography), and total hemoglobin (Drabkin’s method by spectrophotometry), which includes instrument calibration, quality control, instrument maintenance, and result validation • Prepared and presented abstracts as oral/poster presentations at regional/national meetings and manuscripts for submissions to peer-review scientific journals • Assisted in the preparation of grants for online submissions to NIH and the Gates Foundation as well as served as liaison to the Research Management Group Show less

Quality Improvement Fellow

• 2013 - 2013

Project Coordinator Intern

• Jun 2011 - Aug 2011

Coordinated quality improvement projects and handled day-to-day logistics for an Independent Physicians Association (IPA) with more than 600 physicians and close to 40,000 health plan members. Coordinated quality improvement projects and handled day-to-day logistics for an Independent Physicians Association (IPA) with more than 600 physicians and close to 40,000 health plan members.

Project Coordinator Intern

• Sep 2010 - Dec 2010

Supervised the Youth Participatory-Action Research (YPAR) Project in Albuquerque, Detroit, and Oakland. Supervised the Youth Participatory-Action Research (YPAR) Project in Albuquerque, Detroit, and Oakland.

Policy & Advocacy Assistant Intern

• May 2010 - Aug 2010

Conducted advocacy and outreach for 23 member clinics in both counties, serving more than 190,000 patients. Conducted advocacy and outreach for 23 member clinics in both counties, serving more than 190,000 patients.