Elva Lopez

Elva Lopez Email and Phone Number

Clinical Trial Associate at V-Wave Medical @
Elva Lopez's Location
Los Angeles Metropolitan Area, United States
Elva Lopez's Contact Details

Elva Lopez personal email

n/a
About Elva Lopez

• Provide quality administrative support to department managers and staff in the Clinical Development• Experienced in supporting field staff monitors both domestic and globally.• Provided quality support for post-market commitments to regulatory authorities.• Experienced in establishing guidelines to schedule large scale meetings, core team meetings and ad-hoc meetings. * Possess working knowledge of the Code of Federal Regulations (CFRs), good clinical practices (GCP), and ICH guidelines.• Experienced in supporting Phase I, II, III, and IV of sponsor clinical trials. Worked in all trial stages from start-up to close-out.• Provided quality support for clinical trials for new product license applications, line extensions of existing products, and post-market commitments to regulatory authorities.• Experienced in working on clinical trials in Europe, Latin America, and North America and for therapeutic areas in Hemophilia, Oncology, Pulmonary Disorders, and Vaccines.

Elva Lopez's Current Company Details
V-Wave Medical

V-Wave Medical

Clinical Trial Associate at V-Wave Medical
Elva Lopez Work Experience Details
  • V-Wave Medical
    Clinical Trial Associate
    V-Wave Medical Nov 2020 - Present
    United States
  • Lotus Clinical Research, Llc
    Clinica Trial Assistant
    Lotus Clinical Research, Llc Aug 2016 - Mar 2020
    View
  • Baxter International Inc.
    Sr. Clinical Research Coordinator
    Baxter International Inc. Apr 2004 - Jan 2016
    Westlake Village, Ca 91362
    • Worked with Supply Chain and vendors to ensure availability of products and study supplies, providing information to set up study in Clintrials.gov, reviewing applicable SOPs• Assisted in vendor selection and oversight to ensure company policies were followed and performance objectives were accomplished.• Scheduled meetings using Outlook for internal team and vendor meetings, review of study agreements and contracts. This included creating agendas and taking minutes. • Reviewed Master Informed Consent Form templates, which study sites were permitted to use immediately upon approvals of sponsors and local Institutional Review Boards (IRBs).• Assisted in the development, processing, and distribution of protocols, study worksheets, lab manuals, pharmacy manuals, study contracts and budgets, feasibility questionnaires, and study newsletters to the sites.• Handled preparation of site binders, collection of regulatory documents, IRB approvals, and site setups in CTMS.• Managed and tracked study timelines and deliverables through a variety of tools, including SharePoint sites, Microsoft Project, and Excel spreadsheets.• Organized, managed and executed local meetings and training sessions for internal team members as well as external vendor meetings. This process included selecting locations throughout the US, menu selections, travel and transportation logistics and meeting material preparations. • Updated and maintained records in compliance with SOPs and filing requirements in clinical systems, such as CTMS, BaxEdge, and electronic Trial Master File (eTMF).• Prioritized and processed study documents to be provided to Regulatory Affairs to ensure the monthly IND submissions to FDA were completed on time.
    View
  • Baxter Healthare Corp.
    Clinical Project Coordinator
    Baxter Healthare Corp. Mar 2000 - Apr 2004
    Glendale, Ca
    • Assisted Clinical Project Managers in conducting 2-3 clinical trials.• Prepared study investigator binders by creating a master binder used to make adjustments and copies at meeting site.• Provided current copies of approved informed consent templates to sites and distributed updated templates that ensured sites had the most updated templates.• Distributed to sites study information, including protocol, investigator brochures, pharmacy manuals, and other documents through encrypted email that allowed sites to get approval faster.• Collected and reviewed regulatory documents prior to the sites participating in the study.• Reviewed regulatory documents for completeness in a timely manner that enabled Regulatory Affairs to submit updates by target due dates.• Attended core team meetings, created agendas, and recorded meeting minutes to be distributed to team members.

Elva Lopez Skills

Microsoft Office Concur Ariba Baxedge Clinical Trials Management System Isotrain

Elva Lopez Education Details

Frequently Asked Questions about Elva Lopez

What company does Elva Lopez work for?

Elva Lopez works for V-Wave Medical

What is Elva Lopez's role at the current company?

Elva Lopez's current role is Clinical Trial Associate at V-Wave Medical.

What is Elva Lopez's email address?

Elva Lopez's email address is el****@****scr.com

What is Elva Lopez's direct phone number?

Elva Lopez's direct phone number is +180537*****

What schools did Elva Lopez attend?

Elva Lopez attended University Of Phoenix, Los Angeles City College.

What skills is Elva Lopez known for?

Elva Lopez has skills like Microsoft Office, Concur, Ariba, Baxedge, Clinical Trials Management System, Isotrain.

Not the Elva Lopez you were looking for?

View similar profiles

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.