Holly Segura
Escondido,California
Summary
Dedicated Clinical Operations Specialist experienced in complying with study protocols, standard operating procedures and good clinical practices. Successfully manages and oversees clincial study to ensure compliance with relevant local, federal, and state regulatory and institutional policies. Experienced problem-solver with strong attention to detail. Prepared to offer 4 years' of experience in the field and take on a fast-paced position.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Clinical Operation Specialist I
TE IVD Solutions
Carlsbad, CA
12.2021 - Current
- Participates in study start-up activity including site-identification, non-disclosure agreements, contracts, and IRB submissions
- Prepared submissions for Institutional Review Board and filing approvals, amendments, and renewals.
- Collaborates with the Project Manager on the development and preparation of study-specific materials, forms, and processes.
- Supports TMF set-up, maintenance, and on-going quality review of essential documents.
- Works with the supply team in the management of investigational product and ancillary supplies at clinical sites and monitors documentation as appropriate.
- Helps facilitate the resolution of data queries and data requests.
- Reviews and processes study invoices.
- Provided guidance on contract interpretation issues when necessary.
- Prepared draft contracts for review by legal counsel and management team.
- Reviewed and evaluated contract requests to ensure compliance with company policies and procedures.
- Perform additional clinical research, general projects or administrative tasks.
Clinical Supply Supervisor
Toolbox Medical Innovations
Carlsbad, CA
02.2020 - 12.2021
- Maintain active inventory tracking for clinical investigational products and supplies in compliance with company's internal procedures.
- Prepare clinical trial material forecasts at the study level and tracks
material inventory. - Prepare clinical study supplies (Enrollment Kits, Regulatory Binders,
Shipping Materials, etc) - Ship investigational product, clinical supplies and specimens in
accordance with IATA requirements (if applicable) - Review temperature logs and investigates temperature deviations
according to the SOP and protocol. - Track study supplies shipped to Study Sites from Toolbox to destination to ensure safe arrival.
- Developed a system for tracking usage of all materials in the facility.
- Received incoming materials, inspected quality, and prepared receiving reports.
- Monitored employee productivity levels on a regular basis to identify areas of improvement.
- Tracked progress on projects and provided timely feedback to staff members.
Executive Assistant / MRO Assistant
Drug Testing Network
Vista, CA
09.2015 - 07.2018
- Assisted Director of Operations with day-to-day tasks such as managing accounts, contacting new sales leads, and administering drug screens and physicals for clients.
- Managing new and existing accounts requiring both Federally Regulated & Non-Federally Regulated drug screening.
- Ensure clients comply with Department of Transportation Regulations.
- Set up donors with court-ordered private random drug screening programs.
- Assisting clients with document organization, supplies fulfillment and updating account information with vendors.
- Conducted background checks and drafted reports based on in-house Investigation Service findings.
- Assisting Medical Review Officer with daily tasks such as entering and scanning chain of custody forms, analyzing and drafting laboratory affidavits in case of collector error.
- Following up with donors undergoing Medical Review.
- Entering results, MRO reports and reporting to Employers.
- Following up with clinics and collection sites regarding Chain of Custody forms needed for processing.
- Conducting drug screening, specimen collections and breath alcohol testing.
Customer Service Manager
SHAZEEBO
San Marcos, CA
02.2014 - 09.2015
- Training staff on operating procedures, company policies, company services, managing workflow and productivity.
- Promptly followed up on sales leads, invoicing vendors & customers, processing payments and updating accounts once payment is finalized.
- Lead weekly sales meetings for both in-house and online purchases
- Attended yearly trade shows to stay up-to-date on knowledge of product and service changes for both retail and wholesale customers.
- Developed policies and procedures related to customer service operations.
- Design of company website through Bigcommerce site, flyers, catalogs and Merchandise.
- Developed graphics, logos and layouts for product illustrations, company logos, and websites.
Education
High School Diploma -
Valley High School
Escondido05.2010
Some College (No Degree) - Associates Degree
Palomar College
San Marcos, CASkills
- Data Entry
- Research experience
- Client relations
- Extremely organized
- Multitasking
- Time management
- MS Office - Word, Excel, PowerPoint, and Outlook
- Adobe Illustrator and Photoshop
- CRM Program
- Quickbooks Bookkeeping Program
- Customer service
- Standard operating procedures
Certification
- Good Clinical Practice (GCP) Certification
Timeline
Clinical Operation Specialist I
TE IVD Solutions
12.2021 - Current
Clinical Supply Supervisor
Toolbox Medical Innovations
02.2020 - 12.2021
Executive Assistant / MRO Assistant
Drug Testing Network
09.2015 - 07.2018
Customer Service Manager
SHAZEEBO
02.2014 - 09.2015
High School Diploma -
Valley High School
Some College (No Degree) - Associates Degree
Palomar College
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