Debradenise S. Brooks, CRA, CTDM

*** ******* ******, *** *********, CA 94112

510-***-**** ac2t0x@r.postjobfree.com

Objective: Contracted/Full-time Employment with a Sponsor, University, Study Site or CRO as a Clinical Research Associate, Clinical Trial QC Support or Research Support Staff.

SUMMARY OF QUALAFICATIONS:

•Twenty years of Health Care experience – Admin. & Management. Ten years in the Biotech / Pharmaceutical Industry.

•Clinical Research - (CRA, CRC, Consultant) – FDA Compliance/Quality, Systems/cGMP, GLP, GCP

EDUCATION:

• Clinical Trials Design & Management, SFSU 2007

• City College of San Francisco - Course: cGMP, GLP, GCP Spring 2004

• Completion of coursework toward BS degree (IT -Healthcare) Anticipated completion 2017

PROFESSIONAL CERTIFICATION:

Phlebotomy Certification – National May 2004

Certified Clinical Trials Design & Management (CTDM) - SFSU May 2007

Certificate - PPD (CRO) – Introduction to Clinical Research Monitoring August 2010

PROFESSIONAL EXPERIENCE:

Sr. Clinical QC/CT Associate, Dynavax Technologies - Contractor July 2015 – Present Responsible for supporting Clinical Development in executing quality initiatives, performing quality control review of clinical documents, collaborative development and implementation of processes to support compliance in all clinical studies. Manage Internal QC Processes / Procedures related to Clinical Document Control. Liaison between Clinical Operations, Quality Assurance and the CDR. PRS Administrator for ClinicalTrials.gov and active involvement in PLI for recent filing of the BLA.

May 2017: Interim CRA currently involved in the study start-up activities (site feasibility, PQV’s, vendor management, essential document and study plans development reviews, submission, KO meetings, etc. for a Phase Ib - Non-Small Cell Lung Cancer (NSCLC) study. PRS Administrator for Clinical Trials.gov & DRKS (Germany) registry.

Sr. Clinical QA Associate, Dynavax Technologies - Temp November 2014 – July 2015

Duties include, but are not limited to coordinating logistics for Clinical QA audits/inspections, managing the process of routing, review, approval and distribution of controlled clinical documents, ensuring communication within the clinical team on all clinical QA related activities, initiating and follow-up on CAPA’s/ Performing quality control review of clinical documents, such as clinical responses to audit reports, clinical study plans /manuals /protocols, SOP’s, etc. Duties include data listings and safety reviews in prep for end of study data lock and development of CSR. On-going responsibility for oversight of Sites and Vendors in collaboration with the CTM.

Quality Assurance Specific to GCP & E6-R2 guidance.

Quality Control: Document management, SOP’s, ClinicalTrials.gov. etc.

Sr. CRA, Threshold Pharmaceutical – Contractor September 2013 –October 2014

Assumed the role of study manager for “legacy” studies, duties include but are not limited to addressing DM issues, CAPA’s, closing sites, ensuring PI and Site payments accrue under the current budget. Active involvement in study start-up for a Phase II Global trial as the Lead CRA (In-House) duties include, but not limited to EU regulatory filings (i.e. PoA’s, Apostilles), study lead on activates involving study design and execution by contributing operational experience in creating/amending of the study Protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications, etc., Active involvement with Site Qualification activities. Involved in a Global Phase III study start-up planning – including, but not limited to site feasibility, attendance at CRO bid-defense meetings, CRO/Site/Vendor selection.

Monitoring: Site Qualification Visits & In-House - 1 year, 1 Protocol - NSCLC

Sr. CRA, InClin (CRO) – Contractor August 2012 – September 2013

Managing various “internal” projects associated with sponsor’s preparation to file NDA, member of QCOS/SWAT team – performing DBL reviews in preparation of Sponsor’s database lock of a Phase III cancer study. Review of Audit/Quality Evaluation reports for specific Sites & CRA’s and generated CAPA’s as needed. Close-out of several “legacy” studies (Vaccinia) via on site & “in-house” monitoring.

Monitoring: In-House, Interim Site Visits, For Cause and Close-out Visits (1year)

CRA, IPSEN – Contractor November 2011 – July 2012

Oversite of Ipsen transitioning from West Coast to East Coast (specific to study files). Provided support for Phase III endocrine study closure & BLA filing (Pediatric – IGF-1). Duties include, but not limited to in-house & remote management of sites conducting clinical trials, Trial Master File reconciliation, / inspection readiness site and vendor payments, Budget/Finance reporting, Data Management, data listing review and other tasks associated with study close out activities.

Monitoring: In-house and On-Site – All visit types

CTA, Phlexglobal, Inc. – Contractor September 2011 - November 2011

Assist in preparation of documents/files for submission of NDA. Performed quality check and reviews to ensure a successful outcome of client’s on-site FDA inspection. Duties included, but not limited to QC / CAPA of clients Trial Master File to ensure compliance and inspection readiness.

CRA II, BN ImmunoTherapeutics July 2009 – November 2010

Responsibility for managing the internal day to day operations of two Phase II oncology vaccine studies (Prostate & Breast). Duties included the development of study specific documents and tracking systems for Essential documents, management of data tracking systems, and responsibility for IP distribution/accountability. Shared monitoring responsibilities of the study with the CRO's assigned CRA's. .

CRA I, BN ImmunoTherapeutics December 2007 – July 2009

Assured appropriate filing of essential study-related correspondence, clinical and regulatory site documents (i.e. 1572, IRB/IBC approvals, PI licensee, etc.). Assisted with study feasibility assessments for new protocols, assist in the preparation of material for site initiation, site training material, (internal & external staff), study documents (i.e. consent forms, site instructions, etc.). Attended quarterly Sponsor / CRO meetings to address milestones, finances, patient recruitment, etc. Site Initiation visits done as Sponsor representative in collaboration with the CRO.

Monitoring: In-House, On-site Start-up & Interim - 3years, 2 Protocols – Breast/Prostate.

** Prior Health Care / Research experience available upon request **

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