Rebeca Carrillo Email & Phone Number

Dallas, Tx, Us

• Distribute, track, review and approve individual site trial master file (TMF) essentialdocumentation at project start• Collect, review, organize and assemble regulatory submissions• Maintain timelines for study start-up submissions and all subsequent submissions• Provide advice and guidance to internal and external team member to ensure compliancewith applicate regulations and requirements• Review pertinent regulations and guides to develop proactive solutions to clinical trialsubmissions issues and challenges• Collaborate with document center to ensure necessary documentation is present• Train and assist CRAs on the collection of the essential documentation for the ongoingphase of the project

• Transcribed videos and analyzed language development in children acquiring a second language, including both typically developing children and those with speech and language impairments. • Trained incoming students on specialized software, including SALT and inscribe, for transcription and coding • Led progress meetings to monitor timelines and ensure project milestones were achieved.

Dallas, Tx

• Conducts clinical studies across all phases according to Good Clinical Practice, protocolrequirements, standard operating procedures, and federal regulations from start-up tocloseout. Primary indication(s) include Hereditary Angioedema (HAE), asthma, andallergy• Supervise and mentor incoming clinical research coordinators by ensuring propertraining, and provide ongoing support to maintain efficiency and a cohesive team• Serves as a main point of contact for Sponsor, CRAs, and study participants by exercisingstrong written and verbal communication skills with the ability to convey complexmedical and research information clearly• Manage regulatory submissions, obtained necessary approvals from IRBs and maintainup-to-date knowledge of relevant regulations• Collect, process, and properly label and package biological samples for safe andcompliant shipping, adhering to international, national and institutional regulations• Oversee data entry, ensure accuracy, and completeness, perform regular data qualitychecks, and ensure secure storage of study related info• Manage day to day financial functions including payroll approvals, effort reporting,reviewing expenditures, and reconciling monthly

Dallas, Texas, United States

• Maintain protocol requirements for patient visits, patient visit schedules, blood draw, andtest procedures• Responsible for creation of source documentation and applicable updates, participantrecruitment, obtaining informed consent, visit scheduling and follow-up• Prepare and coordinate all on-site monitoring visit• Maintains accurate accountability of study drug inventory and proper monitoring ofstorage conditions.• Assisted in implementing rigorous reconciliation procedures tominimize risk of product loss or discrepancies.

Addison, Texas, United States