Lead Senior CRA Oncology Pharm-Olam

• Jun 2022 - Present

Lead Clinical Research Associate

• Jul 2021 - Aug 2022

Senior Clinical Research Associate

• Sep 2019 - Aug 2022

Oncology Phase I-II Oncology Phase I-II

Senior Clinical Research Associate

• Sep 2018 - Aug 2019

Sr. Oncology CRA - Phase I-II Sr. Oncology CRA - Phase I-II

Clinical Research Associate

• Aug 2015 - Aug 2018

· Experience in Phase II-IV Endocrinology, Dermatology, Oncology, and Immunology · Independently perform SQVs, SIVs, IMVs, and COVs for clinical trial studies.· Effectively communicates with study coordinators and project management updating and troubleshooting study specific issues. · Participate in study meetings (e.g. clinical kick-off meeting with Sponsor and associated vendors, team meetings, etc.) and creates agendas and meeting minutes. · Provide project team support (e.g. shipping supplies to sites and CRAs); follow-up on action items and study-related issues· Assist Project Management with the creation of study-specific document materials and with the acquisition of study supplies· Responsible for set up and organization of study-specific electronic and paper files (e.g. Trial Master Files (Core files) and site level files (ISF Binders) as applicable· Assist in the collection, review, tracking, maintenance, and archiving of Essential Study Documents (ESDs) throughout the life of the study · Assist in study start up process including, site selection, feasibility, IRB liaison, and initial study document draft and review.· Reviewed Master Service agreements, LOIs, Clinical Trial agreements and amendments for verbiage, accuracy and consistency· Provide trip reports within set metrics· Negotiate site budgets · Travel 80%

Regional Contract Mgr / CRA / Owner

• Feb 2015 - Aug 2015

Innovaderm - Canadian Company· Phase III Physician Lead Dermatology study· Independently perform SQVs, SIVs, IMVs· Review protocol compliance at each visit, review CRFs and compare to source documents, review drug accountability, storage and dispensing · Develop timelines, tracking system for each site· Provide project team support (e.g. shipping supplies to sites and CRAs); follow-up on action items and study-related issues· Assist in the collection, review, tracking, maintenance, and archiving of Essential Study Documents· Participate in study meetings· Provide trip reports· Travel 60-70%

CRA/Project Mgr.

• Aug 2012 - Feb 2015

· Phase III-IV: Women’s Health, Urology, Gastroenterology, Rheumatology, Endocrinology· Primary contact between sponsor and PI· Independently perform SQVs, SIVs, IMVs, COVs · Participate in study meetings· Assist in the collection of Essential Study Documents· Check accuracy of CRF entries, source documents and data· Set up studies in Bio-Optronics· IP Accountability· Assist in study start up process including, site selection, feasibility, IRB liaison, and initial study document draft and review.· Negotiate site budgets· Assist study team develop SOPs related to study management· Travel 50-60%

Office Mgr./ Medical Asst.

• Jun 2009 - Jul 2012

· Responsible for training office personnel on HIPPA Compliance · Assist doctor in writing SOPs and office procedures· Create case report forms· Review medical records and transcribe physician notes· Submit patient summary reports for insurance billing· Accounts payable / Accounts receivable · Responsible for training office personnel on HIPPA Compliance · Assist doctor in writing SOPs and office procedures· Create case report forms· Review medical records and transcribe physician notes· Submit patient summary reports for insurance billing· Accounts payable / Accounts receivable

CTA

• Aug 2011 - Dec 2011

· Collect, review, track, maintenance, and archiving of Essential Study Documents· Study start up, feasibility, IRB liaison, and initial study document draft and review· Audit contract CRA timesheets · Collect, review, track, maintenance, and archiving of Essential Study Documents· Study start up, feasibility, IRB liaison, and initial study document draft and review· Audit contract CRA timesheets

CRA I

• Jan 2011 - Jul 2011

· Phase I-III Cardiology & Cardiology Device studies (Heart Failure Network) – NIH Studies· Participate in weekly NIH Budget Executive meetings· Co-monitor / Independently perform SQVs, SIVs, IMVs· Check accuracy of CRF entries, source documents and data· Assist in collecting, reviewing, tracking and maintaining Essential Study Documents· Provide project team support, follow-up on action items and study-related issues· Assist in developing study related timelines· Review and approve country specific ICFs – Canada (French)· Review protocols for discrepancies· Trip/Visit reports· IP Accountability· Risk-based monitoring of ECG patient results· Audit Third Party invoicing· Travel 60%