vasthi becerra

senior study startup management specialist

About

Seven years of experience in physician-initiated and industry-sponsored Phase I-III pharmaceutical and device clinical trials. Specialist in study start-up, maintenance, and close-out with an emphasis on informed consent development, budget negotiations, clinical trial agreements, and submissions for internal review board approval. Strong interpersonal skills, organized, motivated, and focused on meeting company timelines.

Country

united states

City

beaumont

Industry

pharmaceuticals

Skill

clinical trials, pharmaceutical industry, clinical research, clinical development, gcp, cro, ich gcp, ctms, edc, protocol, clinical monitoring, drug development, clinical data management, neurology, clinical study design

Experience

senior study startup management specialist

abbvie

2020-5 - Present · 6 yrs 5 mos

clinical study specialist

allergan

2012-5 - 2015-2 · 2 yrs 10 mos

* Prepared and submitted study protocols to Internal Review Boards for approval * Reviewed study specific informed consent templates * Incorporated Country Specific requirements into Study Model ICF template * Negotiated study budget with research sites * Liaised with legal group and site to negotiate contract language * Distributed and collected all essential regulatory documents from research sites * Managed start-up, maintenance, and close-out activities for Investigator sites * Prioritized workload to ensure research sites were activated for subject enrollment within thirty five days of initiating study start-up activities

clinical research coordinator

south coast clinical trials, inc.

2011-6 - 2012-3 · 10 mos

* Performed study coordinator activities for up to 5 psychiatric clinical trials at a time * Reviewed the informed consent form with study subjects * Obtained all vital sign measurements and blood draws from study subjects * Processed and packaged blood draws * Created source documents to collect study specific information * Entered study data into electronic database capture systems * Maintained the site trial master file * Assisted during monthly monitoring visits

research assistant

ucla

2008-1 - 2011-1 · 3 yrs 1 mo

* Conducted brief primary care intervention studies at four different clinics in Los Angeles * Entered data from paper source documents into eCRFs * Screened patients using the WHO ASSIST assessment * Collected patient data using eTablets