Brenda Y. Whiting
Homewood,USA
Summary
Principal Clinical Research Associate with 30 years of experience as a Clinical Research Associate, including 5.5 years in a large pharmaceutical company's Functional Service Partnership (FSP) model. In the FSP model, interfaced directly with the client by collaborating and supporting the local and central study management project teams. As FSP-CRA, I am exposed to all stages of a trial lifecycle, including Feasibility and site selection, Start-up activities, Site Initiation, Site Monitoring, and Site Close-out activities, participation in internal sponsor meetings, all onsite and remote site visits, etc. Also serves at Veeva CDMS LE. Currently working on 3 trials in the following indication: Pulmonary Arterial Hypertension Previous experience in Clinical trials includes Oncology (Breast, Colorectal, Pancreatic, Brain, Renal) (Lung and Multiple Myeloma). Hemophilia, Lupus, HIV, Rheumatoid Arthritis, GI, COPD, Asthma, MI, Cardiovascular, Endocrine, Vaccine, Mental/Psychiatric (Bipolar, Depression, Schizophrenia) Disorders and Nervous System, phases Ib-IV.
Overview
15
15
years of professional experience
1
1
Certification
Work History
FSP Principal Clinical Research Associate
Thermo Fisher Scientific
01.2023 - Current
- Company Overview: Homewood, IL, USA
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD.
- Provide oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform Initiation, Interim and Close-Out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house local CTMS system for reporting. Review on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Use IVRS for IP setup, accountability and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites.
Senior Clinical Research Associate
GSK R&D
09.2018 - 12.2022
- Company Overview: Collegeville, PA USA
- Perform Initiation, Interim and Close-Out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house local CTMS system for reporting. Review on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Use IVRS for IP set-up, accountability, and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis.
Senior Clinical Research Associate
Novo Nordisk Inc
06.2017 - 08.2018
- Company Overview: Plainsboro, NJ/USA
- Provided oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform Initiation, Interim and Close-Out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house local CTMS system for reporting. Review on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Use IVRS for IP setup, accountability and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites.
Senior Clinical Research Associate
Covance Clinical Development Services
04.2015 - 06.2017
- Company Overview: Princeton, NJ, USA
- Provided oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform initiation, interim and close-out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house document tracking system for reporting. Review on-site investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Oversight of IVRS for IP set-up, accountability, and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites. CRA managed small projects under direction of a project manager/director as assigned. CRA reviewed progress of projects and initiate appropriate actions to achieve target objectives. CRA organized and made presentations at investigator meetings. CRA participated in the development of protocols and case report forms as assigned. CRA acted as contact for clinical trial supplies and other suppliers (vendors) as assigned. CRA was responsible for all aspects of registry management as prescribed in the project plans. CRA assisted in completing the process of serious adverse event (SAE) reporting, process production of reports, CRA assisted with training, mentoring and development of new employees, e.g., co-monitoring.
Senior Clinical Research Associate
Parexel
02.2012 - 04.2015
- Company Overview: Billerica, MA, USA
- Provided oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform initiation, interim and close-out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house document tracking system for reporting. Review on-site investigator files and ensured subject safety by overseeing timely and accurate EA/SAE reporting and follow-up. Oversight of IVRS for IP set-up, accountability, and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites.
Senior Clinical Research Associate
Imclone
07.2011 - 02.2012
- Company Overview: Bridgewater, NJ, USA
- Provided oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform initiation, interim and close-out monitoring visits. Perform 100% or reduced SDV during on-site and remote visits using EDC and in-house document tracking system for reporting. Review on-site investigator files and ensured subject safety by overseeing timely and accurate EA/SAE reporting and follow-up. Oversight of IVRS for IP set-up, accountability, and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites.
Senior Clinical Research Associate
Worldwide Clinical Trials
06.2010 - 07.2011
- Company Overview: King of Prussia, PA, USA
- Provided oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. Perform initiation, interim and close-out monitoring visits. Perform SDV during on-site and remote visits using EDC and in-house document tracking system for reporting. Review on-site investigator files and ensured subject safety by overseeing timely and accurate EA/SAE reporting and follow-up. Oversight of IVRS for IP set-up, accountability, and management. Maintain regular site staff contacts, trainings, and query resolution support. Participate in local interim analysis. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites.
Education
BSN -
Lewis University
Romeoville, IL01.1991
Skills
- Site management
- Pharmacovigilance
- Detailed documentation
- Electronic data capture
Affiliations
Member of the Association of Clinical Research Professionals, Alexandria, VA, USA
Certification
Registered Professional Nurse, 041228614, IL, 1985 exp 2026-05-31.
LANGUAGE(S)
Native Tongue(s): English
Proficient: English
Training
- Complete Self Assigned Training (CRG Learns/Online):
- Professional Development Course
- Time Management
- Project Management Series: Getting Started with Project Management
- Improve Your Communication
Disclaimer
By approving, I confirm that I have reviewed and understand how my information will be used and disclosed by the company, and my associated rights, as set out in the relevant CV Privacy Notice: EU, UK, or for all other countries the Thermo Fisher Colleague Privacy Notice.
THERAPEUTIC EXPERIENCE
- Therapeutic Units & Indications (yrs)
- (Hematology/Oncology): Lung, Hemophilia, Breast, Multiple Myeloma (with more than 20 years of experience in Oncology)
- Infectious & Respiratory Diseases, Indication: Pulmonary Arterial Hypertension (3.5 years)
- (Various) Infection disease, Indication (5 yrs); Cardiovascular (5 years), Women's Health (5 years), GI
- (Psychiatry)Indication (1 years)
- Study Phases
- PH I, II, III, IV Studies
- Patient Populations
- Adult, Pediatrics
- Global/Regional Scope
- North America
ADDITIONAL RELEVANT EXPERIENCE
- 6MWT
- REVEAL LITE SCORE
- RECIST/IRECIST
- COMPUTER EXPERIENCE: MICROSOFT
- ELECTRONIC DATA CAPTURE: VEEVA, INFORM, MEDIDATA RAVE, CTMS
- IWRS: RAMOS, ORACLE, ATERO
- VESTIGO, NCOUP, COMPLION
Timeline
FSP Principal Clinical Research Associate
Thermo Fisher Scientific
01.2023 - Current
Senior Clinical Research Associate
GSK R&D
09.2018 - 12.2022
Senior Clinical Research Associate
Novo Nordisk Inc
06.2017 - 08.2018
Senior Clinical Research Associate
Covance Clinical Development Services
04.2015 - 06.2017
Senior Clinical Research Associate
Parexel
02.2012 - 04.2015
Senior Clinical Research Associate
Imclone
07.2011 - 02.2012
Senior Clinical Research Associate
Worldwide Clinical Trials
06.2010 - 07.2011
BSN -
Lewis University