Sector Experience

Life Sciences & Pharma
25
years

Years of Experience

2/20

Member Since


Fortune 500

Experience

 
DOCS Global Research
Senior CRA, Contractor
08/2020 - 08/2021
Pfizer Covid-19 Vaccine Phase 1, 2, 3 clinical trials - primary CRA, monitor for 3 research sites that enrolled approximately 2000 subjects participants total.

Avanir Pharmaceutical Operations
Independent contractor, field monitor
01/2018 - 06/2019
conduct site qualification, site initiation, interim monitoring and close out visits, site management, regulatory documents review and submission, TMF submissions through Veeva Vault/CTMS

MedSource Operations
Lead CRA
03/2015 - 10/2017
Lead CRA for two Phase 3 In-patient epilepsy trials; managed CRA/monitors' visit schedule, review and approve trip reports; reviewed regulatory documents, managed eTMF files through cloud based storage systems and Veeva Vault; conduct pre-study, initiation, interim monitoring visits; provided training to study site staff and hospital staff involved in the trials.

Otsuka Operations
Clinical Trial Lead
11/2008 - 02/2015
Managed the conduct of multiple trial activities with CROs; oversight of CRO monitors to ensure GCP compliance for global trials; reviewed TMFs at study and site level, preparation for QA audits and regulatory inspection.

RPS Other
Contractor Drug Safety Associate
07/2006 - 11/2008
Supported Clinical and Drug Safety team to close out studies in preparation for final study reports and regulatory filing. Supported regulatory team to review TMF, regulatory submissions for FDA filings

Sigma Tau Operations
Clinical Trial Manager
01/2005 - 02/2006
Managed Phase 2 cardiovascular trial; breast cancer pain management study start up activities; supported clinical team with protocol development; review and update SOPs and various working guidance documents for operations team.

AstraZeneca Operations
Clinical Scientist
02/2002 - 12/2004
Managed Phase 2 and Phase 3 trials for Nexium; supported study team with critical study data review, regulatory and TMF documents in preparation for audits and inspections preparation; Managed Phase 3 studies with IBS studies; provided oversight of vendors and academic research centers involved in clinical trials.

Baxter International Operations
Clinical Project Manager
02/2000 - 12/2003
Managed phase 2, 3 and 4 vaccine trials; developed study document tools and contributed to study protocol writing, safety reports submission; oversight of regulatory documents and TMF reviews.

Bristol Myers Squibb Operations
Clinical Scientist
11/1997 - 02/2000
Supported clinical team with CNS and Infectious Disease clinical trials with study set up, protocol development, start up activities including investigators' meeting presentation, training materials and regulatory documents review.

Otsuka Operations
Clinical Research Associate
08/1995 - 11/1997
Supported team with Phase 1 trials study set up to include protocol and CRF development, monitored phase 1 and phase 3 trials; review and set up of site TMF files