Barbara White
Clayton,USA
Summary
Seasoned clinical research professional with over 15 years of experience in many facets of research development. Excellent knowledge of the research and GCP progress. Have worked from multiple spectrums in the research industry, including site level, CRO and SMO with excellent knowledge of all. Exceptional computer skills, including company specific databases, eTMF, EDC, CTMS and adapts to new systems quickly with little instruction. Interested in working with sites, possibly in start-up, site activation, or in-house monitoring for late phase studies.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Clinical Study Start-Up Coordinator
Lightship
01.2022 - 04.2022
- Conducted site identification searches on internet, company database and other means
- Regulatory submission to central IRB
- Collection of essential documents for potential sites
- Conducted presentations for site network qualifications
- Completed site qualifications survey as well as ran company required background checks through government sites
- Interaction with sites to assure they were kept up-to-date on study progress
- Assure all documents received from site were maintained in site files on shared drive and eTMF
Contract Clinical Research Coordinator, Study Manager
Peak Clinical Trials
02.2019 - 05.2020
- Perform clinical trial requirements per GCP guidelines
- Review protocols and attend monitoring meetings
- Identify patients for enrollment
- Screen subject via phone to assure qualified
- Conduct visits per protocol
- Maintain all regulatory documents, update as needed
- Distribute and negotiate contracts and budgets from sponsors and CROs
Site Manager II – In-house Monitor – Real World, Late Phase Studies
IQVIA (Contract)
05.2018 - 02.2019
- Served as the primary point of contact for investigative sites from start-up through close-out to ensure that assigned clinical trials were conducted in compliance with the protocol, CRO/Sponsor SOPs, ICH GCP, and applicable regulations
- Established regular lines of communication with participating sites in accordance with operational plans and contracted scope of work to manage ongoing project expectations and timelines
- Performed start-up activities including collecting and reviewing essential documents for completeness and accuracy, negotiating site contracts and budgets, reviewing ICF revisions, and completing study and site level IRB/EC submissions
- Evaluated the quality and integrity of study site practices, escalated issues, and implemented corrective action plans
- Kept CTMS current for accurate and timely reporting; submitted required study documentation to the TMF and maintained central site files
- Supported study teams in the successful start-up of new projects through the development of monitoring plans, creation of regulatory binders, and establishment of clinical tools, processes, and guidance documents
Quality CRC
CTMG, INC
09.2017 - 05.2018
- Attend daily meetings to provide and receive updates from other service teams
- Attend protocol specific training sessions
- Conduct trial activities according to federal and state regulations
- Assist the PI in ensuring safety and wellbeing of subjects
- Coordination of clinical trials in physicians’ offices including: prescreening, recruitment and screening
Manager, Study start Up/Site Identification
Quintiles/IMS
09.2010 - 09.2017
- Managed 18+ direct reports, including leads, coordinators and follow up with the team
- Conducts yearly performance review and quarterly discussions about goals and career pathways
- Set up and conduct interviews for new resources
- Provide assistance with completion of tasks to meet timelines
- Provide training/retraining as needed
- Lead monthly project review to management to assure that timelines are met/discuss red projects and provide solutions for conclusions
- Utilize programs and databases to assure that contact of site personnel is up to date
- Verify credentials of PIs/QA status is in good standing
Lead Site Identification Specialist II
Quintiles/IMS
10.2010 - 03.2016
- Organize and lead pre-study meetings with Clinical Team Leads, Project Managers and Medical Advisors and Site Start Up to propose strategy for identifying potential Investigators for a given study
- Utilize site performance metrics, business relationships, databases, and targeted web searches to identify potential study sites
- Ensure quality assurance review of all potential investigators
- Maintain and manages data tracking entries into designated clinical tracking systems in accordance with project requirements
- Mentor Junior department staff
Manager, Study start Up/Site Identification
Quintiles/IMS
09.2008 - 09.2010
- Work with sponsors and internal team members to establish boilerplate documents necessary for Start Up, including Confidential Disclosure Agreements and Site Information Questionnaires
- Distribute CDA’s, SIFs and other relevant documentation to investigator sites, follow ups as necessary and tracks activity
- Report on Project Process to Clinical Team Leads, Project Managers, Site Start Up and Department Management
- Collaborated with Clinical Trial Leaders and Project Managers with determining final study roster
- Updated investigator database throughout project and ad hoc basis when contacted by sites or instructed by management
- Perform internet searches to enhance investigator database and identify non- experienced physicians to start up studies at their sites
Site Relations Specialist I
Quintiles
06.2006 - 02.2008
- Reported on project progress to Clinical Team Leads, Project Managers, Site Start Up and department management
- Collaborated with Clinical Trial Leaders and Project Managers with determining final study site roster
- Updating investigator database throughout project and on ad hoc basis when contacted y sites or instructed by management
- Mentored new employees on SOPs and processes
- Team lead for first “mega project” with as many of five employees working under my instruction
Education
Medical Assistant Diploma - undefined
American Medical Training Institute
High School Diploma - Business
Thomas Stone High School
Skills
- Microsoft Office
- Powerpoint
- Excel Sharepoint
- IM
- Infosario
- ETMF
- Informatics
- Study Mgr
- Salesforce
- Clinical Conductor
- Inform/Phase Forward/Rave EDC
- Clinphone and other IVRS systems
- IVRS Systems
Certification
- Certified Clinical Research Coordinator, ACRP 2001-2010
- National Medical Assistant Registry-1991
- Certified Medical Assistant-1991
CUST
Revised: March 2024
Timeline
Clinical Study Start-Up Coordinator
Lightship
01.2022 - 04.2022
Contract Clinical Research Coordinator, Study Manager
Peak Clinical Trials
02.2019 - 05.2020
Site Manager II – In-house Monitor – Real World, Late Phase Studies
IQVIA (Contract)
05.2018 - 02.2019
Quality CRC
CTMG, INC
09.2017 - 05.2018
Lead Site Identification Specialist II
Quintiles/IMS
10.2010 - 03.2016
Manager, Study start Up/Site Identification
Quintiles/IMS
09.2010 - 09.2017
Manager, Study start Up/Site Identification
Quintiles/IMS
09.2008 - 09.2010
Site Relations Specialist I
Quintiles
06.2006 - 02.2008
Medical Assistant Diploma - undefined
American Medical Training Institute
High School Diploma - Business
Thomas Stone High School