GAIL HODGINS

1078 Fordham Street, Pittsburgh, PA 15226(412) 321-4083 email: gailhodgins@verizon.net

SUMMARY: 18 plus years progressive advancement in clinical trials implementation and management.

Taught at San Francisco State University, Clinical Trials Design & Management, College of Extended Learning.Ten years clinical analyst experience.12 years volunteer health advocacy and public speaking.Knowledge of GCP regulations, ICH guidelines.Indications: Myocardial Perfusion Imaging, Coronary Artery Disease, Paroxysmal Supraventricular Tachycardia, Chronic Pain, Liver Transplant Immunosuppressant, AIDS Related Non-Hodgkin’s Lymphoma, Kaposi’s Sarcoma, Age Related Macular Degeneration, Prostate Cancer, Cardiac Ultrasound Imaging, Migraine, Dry Eye disease, HIV disease and Seasonal Allergies.

EMPLOYMENTSenior Clinical Research Associate ProTrials Research, Inc., Mountain View, CA. June 2002-Present

Regional Monitor performing all aspect of site monitoring from qualification visits to close-out visits on various Phase I, Phase II and Phase III clinical trials

Assisting study start-up of large Phase III coronary artery disease trial, including site identification, qualification visits, contracts, vendor management, and budgets.

Project management on two Phase II coronary artery disease trials. Supervised regional monitors, vendors, and worked closely with the sites to meet goals. Managed study close of Phase III Paroxysmal supraventricular tachycardia trial which included query

resolution, data reconciliation, internal audits and drug reconciliation.

Instructor, San Francisco State University, Clinical Trials Design & Management

Designed and taught Clinical Trials Monitoring class, San Francisco State University. July - September 2003

Clinical Research Associate III Elan Pharmaceuticals, South San Francisco, CA. January 2000-April 2002Clinical Research Associate II Clinimetrics Research Associates, Inc., San Jose, CA. August 1998-January 2000

Managed CROs providing monitoring and data management on multiple Phase III trials. Managed study sites addressing protocol, regulatory and case report form questions. Assured complete regulatory documentation on file at sites and sponsor central files. Managed regional monitors. Developed study drug supplies management tools and coordinated management with Clinical Material

Management for three concurrent and future studies, including timely ordering of new supplies and labeling Performed all closeout procedures working with study coordinators and data management for query resolution

prior to data lock. Participated in writing protocols, developing site budgets, designing case report forms for Phase III trials. Monitored study sites on Phase II/III clinical trials. Lead in-house CRA on long-term study for efficacy and safety on chronic pain clinical trial. Trained contract CRAs, new team CRAs, and Administrative Assistant on study duties. Tracked study safety profiles for Adverse Event and Serious Adverse Event reporting according to FDA and GCP

guidelines. Triaged Serious Adverse Event reporting in liver transplant trial with study sites and medical monitor for

consistency and compliance. Resolved accumulated site grant payment for multiple sites. Obtained documentation, assured financial

accountability and diplomacy in interactions. Trained other CRAs on performing site payments and payment reconciliation. Responsible for the return of initial unused site grant monies when required.

Gail Hodgins – Page 2

Clinical Trials Coordinator UCSF Positive Health Program, Independent Clinical Trials Group, SanFrancisco, CA. July 1997 – August 1998. Performed as the primary research coordinator for investigators at different sites under the auspice of the AIDS Malignancy Consortium. Responsible for site coordination of NIH investigator initiated Phase I, II, and III clinical research protocols related

to AIDS associated Non-Hodgkin’s Lymphoma and Kaposi’s sarcoma. Coordinated multiple patient scheduling and assured completion of all study related procedures including

patient understanding of Informed Consent and treatment options. Accountable for clinical research source documents, case report forms, answering data queries and providing

resolution. Developed tracking materials from protocols, maintained clinical and sponsor files in accordance with GCP and

FDA guidelines.

Administrative Analyst UCSF Mobile Mammography Van, San Francisco, CA. September 1987- July 1997. Nine years experience complying with FDA and Medicare regulatory requirements for a UCSF mammography facility. Managed clinical results reporting process with clients and physicians. Served as client case manager to ensure follow-up in compliance with regulatory requirements. Designed and implemented Medicare and Managed Care billing systems for the department, requiring coding

verification and client relations. Managed film library of over 86,000 mammograms, including archiving, routing and distribution mechanisms. Responsible for ledger and insurance billing reconciliation, supply and equipment procurement and inventory

control. Supervision of office support staff.

COMMUNITY SERVICE

Advocacy and Public Speaking Board member of the Tenderloin AIDS Resource Center (TARC) 1998-2001 Instrumental in starting a non-profit organization which addressed the issues of parents with HIV positive children. Participatory experience in informing women and families on how to advocate for increased funding for HIV research, prevention and education. Published works on psychosocial issues related to families and HIV, nationally and internationally. Powerful presentation techniques when advocating internationally on HIV/AIDS related issues. Acted as a liaison between parents and children to bridge the gap in attitudes and beliefs regarding HIV/AIDS.

EDUCATIONMaster of Fine Arts, San Francisco Art Institute, San FranciscoBachelor of Fine Arts, San Francisco Art Institute, San Francisco

CLINICAL RESEARCH TRAININGDrug Information Association, Annual Meeting, July 2015Drug Information Association, Annual Meeting, July 2008Auditing Techniques for Clinical Research Professionals, Barnett International, September 2006American Society of Nuclear Cardiologists Conference, October 2004Cancer: Pathophysiology, Current Therapies, Clinical Trials and Drug Development, April 2003Study Audits, ProTrials, 2002HIPAA Regulations, ProTrials, 200221 CFR Part 11 Compliance Training, December 2001Advance CRA Training, May 2001Regional CRA Training Meeting, November 2000