***** ****** *******. ********* ****, CA ***** M: 650-***-****

ad3f2p@r.postjobfree.com

Summary

Clinical Research Consultant with experience as a Clinical Research Associate, Clinical Trial manager, and Clinical Research Coordinator; qualified with 19 years of industry experience. Regional field monitoring experience and global trial management experience in Phase 1, 2, 3, 4, and post-marketing trials, include registry studies. Thorough knowledge of various EDC platforms, eTMF, and working knowledge of 21 CFR Part 11 compliance. Experience in vendor management, conducting CRA assessment visits, implementing and managing CAPAs, developing SOPs/process documents, conducting site qualification, initiation, interim, and close-out visits, and experience in preparing investigative sites for sponsor and agency audits. Therapeutic indications include HIV/AIDS, Glioblastoma (GBM), Alzheimer’s Disease, Prostate Cancer, Depression, Migraine, Oral Mucositis (OM), and Osteoarthritis

Professional Experience Organogenesis, Inc.

Clinical Research Associate, Consultant December 2021 to December 2023

•Oversight of investigators and their site personnel compliance with study protocol, clinical trial timelines, ICH-GCP and applicable regulatory guidelines.

•Conducted site evaluation, initiation, interim monitoring, and close out visits.

•Performed routine on-site visits including IP accountability, query resolution, source document verification, ISF document maintenance, and CAPA management.

•Conducted User Acceptance Testing of EDC platform.

•Participated in cross-functional study team meetings with internal and external resources.

•Proactively identified and resolved issues and participated in process improvement initiatives as required.

•Conducted training/field assessment visit of junior CRAs.

Axsome Therapeutics September 2019 to November 2021 Clinical Research Associate, Consultant

•CRA- migraine/depression/ Alzheimer’s Disease

•Risk-based monitoring and onsite monitoring; Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits

•Maintaining audit-ready clinical study sites: 15 sites

•eTMF management

IQVIA

Clinical Research Associate, Consultant March 2019 to September 2019

•CRA- oncology\Glioblastoma Multiforme

•Remote EDC and on-site SDV monitoring; Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits

•InForm 6.2 EDC platform

Tocagen, Inc.

Clinical Research Associate, Consultant August 2017 to April 2019

•CRA –Glioblastoma Multiforme

•Remote and on-site SDV monitoring; Interim Monitoring Visits. Managed 7 clinical sites.

•eCaselinks EDC

•Veeva Vault TMF management

IQVIA (formerly Novella Clinical Research)

Clinical Research Associate, Consultant July 2014 to December 2018

•CRA –oncology\Glioblastoma Multiforme\Prostate Cancer \ Oral Mucositis

•Remote EDC and on-site SDV monitoring; Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits

•Inform 6.0 EDC platform

Monitor for Hire

Clinical Research Associate, Consultant May 2012 to February 2013

•Conducted Site Qualification Visits at research sites and hospitals for a surgical site infection (SSI) trial

•Conducted Site Initiation Visits for selected sites

•Responsible for un-blinded monitoring activities including training of clinical site pharmacist

•Managed the initial and resupply of study drug/clinical supply materials including drug accountability and reconciliation

Ipsen Biopharm

Brisbane, CA

Clinical Trial Manager, Consultant July 2011 to November 2011

•Managed study close-out activities, including TMF reconciliation and preparation for internal QA audit

•Coordinated activities and transfer responsibilities to the European offices due to CA closure

Affymax, Inc.

Palo Alto, CA

Clinical Operations Consultant January 2011 to May 2011

•Managed Phase 3 inventories, while working with CROs to ensure document- level inventory of the TMF was achieved prior to transfer

•Implemented the DIA Trial Master File Reference Model (DIA TMF RM),both electronically and hardcopy

•Developed SOPs and tracked issues from recent mock audit; performed follow-up on corrective action plans with investigative sites and CRO to ensure issues were appropriately resolved.

Exelixis, Inc.

South San Francisco, CA

Clinical Trial Manager II January 2010 to Dec 2010

•Managed CRO and vendors, including preparing requests for proposals and reviewing metrics

•Managed study close-out activities, including TMF reconciliation, IP reconciliation, and preparing sites for internal audit; implementation of Corrective Action Plans including measuring effectiveness to optimize existing processes, and tracking until resolution.

•Involved in site start-up activities, including regulatory and budget issues

•Monitored overall study progress and maintenance of timelines

•Interacted with other functional areas to identify issues and participated in the resolution of such findings

•Responsible for site and vendor training on protocols, EDC, and eCRF completion guidelines while adhering to 21 CFR Part 11.

•Conducted CRA assessment visits for all monitors across multiple protocols.

•Provided updates and recommendations to management as the Project Team Lead

Genentech, Inc.

South San Francisco, CA

Clinical Trial Manager, Consultant March 2007 to February 2009

•Responsibility included managing various aspects of a multi-center clinical trial in GBM including vendor and CRO management

•Conducted monitoring visits, CAPA visits, and site inspection visits.

•Created the Trial Monitoring Plan

•Managed and prepared investigative sites for compliance audits, implemented corrective action plans, and provided responses to the audit findings.

•Trained both sponsor and service provider personnel on clinical trial specific procedures. Conducted CRA assessment visits for all monitors

•Coordinated and managed the transfer of a newly acquired molecule to aTaiwanese- based biotech, while managing the active trial in the US

•Conducted user access training for the IVRS/IWRS

•Provided Clinical Operations functional input and review on trial-related charters, process documents, and study-specific issues.

•Conducted TFL reviews, ICF reviews, and TMF reconciliation on global trials.

Actelion

Brisbane, CA

Clinical Research Associate, Consultant July 2006 to March 2007

•Provided site management and project development coordination for a 3000patient Registry

•Assisted with the design and implementation of the Electronic Data Capture (EDC) System

•Provided training and technical advice to site personnel and project team members on electronic CRF completion

•Performed remote review and onsite EDCmonitoring

•Conducted site initiation visits and interim monitoring visits at investigative sites.

•Completed monitoring reports; conducted follow-up on outstanding action items and implemented corrective action plans when necessary

•Designed and developed EDC reports to track study metrics including document submission, and investigator payments

•Identified enrollment issues and participated in the resolution of suchfindings.

•Communicated with sponsor, central laboratory, eCRF vendor, sites and colleagues to ensure effective project management.

Gilead Sciences, Inc.

Foster City, CA

Clinical Research Associate February 2005 to July 2006.

•Managed regulatory documents, clinical trial manuals and drug binder including management and submission of international site closure letters to the appropriate regulatory agencies.

•Managed and monitored four separate protocols across ten sites in theLos Angeles, San Francisco, and Phoenix areas.

•Conducted filing of Trial Master File documents and internal site fileaudits.

•Prepared Clinical Study Reports Appendices including Investigator List, Financial Disclosure list, IRB list, and Debarment List

•Conducted investigator assessment/site selection visits, site initiation visits, interim-monitoring visits, and closeout visits at investigative sites. Completed and submitted all monitoring reports to the TMF; follow-up on outstanding action items until resolution was reached.

•Designed patient tracking charts using spreadsheets and formulated source documents and data collection charts.

•Assisted sites with learning and maintaining Good Clinical Practice

•Provided review and feedback on eCRF development and site trainingmodules.

•Conducted review of Informed Consents for accuracy and adherence to federal regulations, GCPs, and protocol; completed Serious Adverse Event (SAE) narratives.

•Performed data listings review, processed site payments, and evaluated change order requests.

NorthStar Medical Center

Chicago, IL

Senior Clinical Research Coordinator April 2002 to January 2005.

•Accountable for overseeing all phases of the clinical trial process, which included, initial budget negotiations, site inspections, IRB contact, promotion and recruitment, enrollment and study closure

•Coordinated patient study visits and procedures including specimen processing.

•Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts.

•Completed IND safety reporting procedures per regulatorycompliance; maintained IRB annual renewals and SAE reporting/follow-up

•Managed drug accountability and documentation for each study including source documentation, CRF completion, eCRFs completion, and query resolution

•Developed relationships with community leaders and organizations to assist with patient education and subject recruitment

•Responsibilities included training staff, patients, and home healthcare providers on Fuzeon reconstitution and injection. Facilitated monthly group meeting for patients facing challenges associated with Fuzeon adherence

•Worked closely with ADAP and various patient assistance programs to ensure continued access to medications.

Protocare Trials, Inc. - Chicago Center for Clinical Research

Chicago, IL

Clinical Research Coordinator/DEXA Technician August 1999 to April 2002.

•Coordinated patient study visits and procedures.

•Coordinated with Investigator and Sub-investigators, the scheduling, preparation and provision of education and information regarding clinical protocols.

•Collected and maintained study documentation and communication reports. Acted as a liaison between the regulatory department and the Sponsor.

•Managed drug accountability and documentation for each study including source documentation, CRF completion, query resolution.

•Performed DEXA scans.

Computer skills:

•Microsoft (Word, Excel, Outlook, PowerPoint), CTMS, ShareVault, Oracle InForm 6.2, eCaselinks EDC, iMedidata RAVE Clinical, IBM Clinical, Veeva Vault

Education

San Francisco State University December 1996

Bachelor of Science in Nutritional Science

Certifications/Webinars/eLearning

Barnett International- Clinical Research Auditing Certification Program

2022

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

2019

Inspection Readiness- Beginning with the End in Mind

2019

ICH Gap Analysis

2019

The Path of Least Resistance- Managing Opposition to Change 2019

Barnett Expert GCP Accreditation Exam 2016

Contact this candidate