Lisa A. Benson, BS CCRP, CRCP 9 Vexation Hill Drive Rocky Hill, Connecticut labenso@connecticutchildrens.

Transcription

1 Lisa A. Benson, BS CCRP, CRCP 9 Vexation Hill Drive Rocky Hill, Connecticut labenso@connecticutchildrens.org Education: California Coast University Santa Ana, CA Bachelors of Science in Health Care Administration Magna Cum Laude Lasell College Newton, MA Associate Degree Science Computer Programming Classes Central Connecticut State University New Britain, CT Professional Memberships: Southwest Oncology Group (SWOG) National Surgical Adjuvant Breast and Bowel Project (NSABP) Children s Oncology Group (COG) Society of Clinical Trials Present (SoCRA) Present Society of Research Administrators Present NCURA Present MAGI Certifications and Continuing Education MAGI Certified Clinical Research Contract Professional: May 2010 to present Certified Clinical Research Professional(CCRP): April 1995 to present Required to complete 45 CEU s every three years. These credits have include classes and seminars on FDA guidelines, Auditing Clinical Trials and Good Clinical Practices, Contracting and Negotiating Clinical Trials, Conducting Quality Clinical Trials, Developing Clinical Study Budgets, Monitoring Clinical Drug Studies (Barnett International), Research Compliance, Clinical Trials Management (Bowman Gray School of Medicine). 1

2 Research Experience: 2008 Present Director of Research Administration and Sponsored Programs Department of Research Connecticut Children s Medical Center Hartford, CT Manages daily pre- and post-award operations, staff and constituent training, information systems, audit and compliance activities for all research activities. Maintain in-depth knowledge of state and federal policies and procedures related to industry sponsored trials, grants and sponsored programs. Advise faculty and oversee the preparation of grant and contract proposals. Develops and writes sub contracts to consultants, outside agencies and other institutions as needed. Analyze project resource requirements and develop budgets for proposals. Responsible for the contractual, regulatory and financial management of all research studies. Coordinate and integrate sub-award recipient documentation into proposals. Provides consultation to CCMC physicians and research staff in the areas of research and protocol development, research compliance and study management. Develops and presents education and training activities related to management of clinical trials and clinical research. Develop and perform internal audit processes for quality control and quality improvement purposes. Direct and oversee performance of sub-recipient monitoring plans. Development and management of multi-center research registries. Serves as administrative and financial liaison to all participating centers. Communicates directly with sponsors, vendors, outside legal consultants on matters related to research contracts. Initiates contacts and maintains liaisons with internal and external partners to support the functioning and continued growth of the Department of Research. Responsible for the delivery of all components of clinical trial financial management inclusive of establishing and directing financial policies and procedures which promote compliant financial research management. On behalf of CCMC, negotiates clinical research agreements and contracts and budget detail with sponsors and others to arrive at mutually acceptable and executable agreements Manager Research Administration and Finance Department of Research Connecticut Children s Medical Center Hartford, CT Responsible for the administrative, contractual, regulatory and financial management of all research studies conducted within the Clinical Trial Unit and the Department of Research. Develops, negotiates and finalizes clinical trial contracts between CCMC and sponsors or other agencies. Responsible for project administration and management of multiple research projects including the review of all proposals, budgets, contracts and regulatory documents. Develops all study budgets for research projects and manages all financial requirements for a clinical trial or research study. Manages post award administration of multiple clinical trials, (cost center set up, compliance, monthly reconciliation and financial reporting). Developed and maintained financial tracking for payments received and disbursements. Ensures that all contractual deadlines are adhered to and maintained a effective working relationship with sponsors, investigators, contract research organizations (CROs), external agencies and other research staff. Served as a research consultant in the areas of research and protocol development, research compliance and study management for faculty and staff at CCMC. Served as the administrative representative and contact with the national agencies such as National Institute of Health (NIH), National Cancer Institute (NCI), Pharmaceutical Industry and other hospitals. Provided education in clinical trial management and research compliance to Investigators and research staff and developed and implemented policies and procedures for the Department of Research. 2

3 Clinical Research Associate General Clinical Research Center Assisted Principal Investigators (PI) in the design/development of complex research projects, funding and grant applications. Organized data for grant applications and progress reports. Prepared and submitted protocol applications, continuations and informed consents to Institutional Review Board IRB. Reported adverse events to appropriate personnel. Coordinated, trained and oversight of staff for large, complex multi-center clinical research studies. Interacted with patients to register, review eligibility, and ensure completion of informed consent prior to participation in research projects. Facilitated clinical nursing staff for clinically related study procedures. Oversaw the procurement, preparation and shipping of research specimens. Participated in developing quality standards and educational programs. Monitored and ensured quality of projects in accordance with institutional policies and standards, IRB and State/Federal regulations. Participated in evaluation and implementation of data collection methodologies, protocols, database systems and techniques according to the established protocol. Reviewed medical records and other necessary sources in order to abstract information. Served as a resource or mentor to other research staff across the organization s research infrastructure. Completed IND applications and annual reports to the FDA. Monitored a multi-center study for an investigator initiated studies which held an IND. 8/ Administrative Manager of Pediatric Hematology/Oncology Department of Pediatric Hematology/ Oncology Responsible for managing the day-to-day operations for the Pediatric Hematology/Oncology Department. Primary responsibilities will include the utilization of all resources to achieve departmental goals for productivity, scheduling, patient access, and staffing. Approve all departmental expenditures, plan and implement new policies and procedures, order equipment and supplies as needed. Responsible for department budget and expenses. Clinical Research Associate Department of Pediatric Hematology/ Oncology Managed the initiation of clinical trials for the pediatric oncology department according to regulatory and institutional guidelines and requirements; registered and enrolled eligible patients and facilitated the studies. Responsible for the extraction, compilation and evaluation of data submitted. Responsible for study compliance, monitoring and maintain on-going regulatory requirements. Provided information and feedback on designated clinical trials; coordinated the data management systems and administered protocol operations within the institution. Oversee protocol development and management at the institutional level to ensure appropriate team review, ethical approval, cost effectiveness and study activation is undertaken before patient accrual begins. Maintain regulatory integrity of each study and assist in grant and budget development to include individual study grants and per case reimbursement. Protect subjects through timely data submission, regulatory compliance and adverse event reporting. Contribute to the success of clinical trials through COG CRA committee participation. Assist pharmacy with drug accountability. Developed institutional informed consent documents for all COG protocols, maintain regulatory integrity of protocols through preparation and submission of the protocol, consent form, protocol amendments and annual progress reports to IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the COG specified timeline. Through participation on the audit committee of COG, I audited over 20 sites across the country for the NCI mandated cooperative group audits. 3

4 Medical Assistant Department of Lab Medicine COMMITTEE APPOINTMENTS: September Board Member January 2000 June 2003 Childrens Oncology Group Vice- Chair Clinical Research Associates Childrens Oncology Group Member Clinical Research Associates Steering Committee Childrens Oncology Group Member Institutional Performance and Monitoring Committee September January 2000 Member of Executive Committee Co-Chair Clinical Research Associates Transition Committee Member of Clinical Trials Support Unit Member of Performance Monitoring and Quality Assurance Committee February January 2000 Chair, Clinical Research Associates Committee Member of Executive Committee Member, Audit Committee 4

5 March February 1997 Vice- Chair, Clinical Research Associates September September 1999 Member, Membership Committee January September 1996 Chairman, Communications Committee September September 1996 Board of Directors September 2014 Global Pediatric Clinical Research Network Advisory Board October 2014 September 30, 2015 NCURA - Spring Meeting Educational Program Committee Member NATIONAL PRESENTATIONS: April , St. Louis, MI; November Dallas, TX; September , Bloomington, MN; June 1998 Childrens Oncology Group Arcadia, CA; March Childrens Oncology Group, Dallas, TX; October Childrens Oncology Group San Antonio, TX; April Childrens Oncology Group St. Petersberg, FLA; November Childrens Oncology Group St. Louis, MI; March Childrens Oncology Group Atlanta, GA; May Data Safety Monitoring Plans University of Connecticut Health Center; September 2006-SoCRA Annual Conference Centralized Services in Clinical Research, SoCRA Annual Conference- Developing Budgets for Clinical Trial Research; September 2008 SoCRA Annual Conference Centralized Services Budgeting and Compliance ; May 2009 MAGI Conference Workshop Presenter - Budget Development and Negotiation for the Investigative Site; September 2009 SoCRA Annual Conference Budgeting and Contract Negotiations; April 2010 NCURA Region 1 Annual Meeting - Session Presenter- Effective Budgeting for Clinical Trials; May 2010 MAGI Conference- Workshop Presenter - Budget Development and Negotiation for the Investigative Site; September SoCRA 2010, 2011, 2012, 2013, 2014 Annual Meeting Workshop Presenter- Clinical Research Administration Budgeting, Contract Negotiation and Finance: A Sites Perspective ; Session Presenter - Best Practices for Sites and Sponsors to Reduce the Budget Negotiation Cycle ; SoCRA Program Management Workshop Session Presenter Taking Budgeting To The Next Level 2010, 2011, 2012, 2013, 2014; NCURA 2010, National Meeting Workshop Presenter- Negotiation Skills for Research Administrators. NCURA 2011 National Meeting Workshop Presenter, A Workshop Designed to Provide Actionable Insight into the Kaleidoscope of Clinical Trials and Research Administration; NCURA 2012 National Meeting Workshop Presenter, Solving The Rubik's Cube Puzzle of Clinical Trials and Research Administration ; NCURA 2013 National Meeting Presenter- Solve the Gordian Knot and Rule the World of Research Administration and Clinical Trials" NCURA 2014 National Meeting Presenter - Understanding Research Administration and Clinical Trials Pocket Edition: Chapter 1 NCURA 2015 National Meeting Prsenter - _Key to Understanding Research Administration and Clinical Trials; NCURA Region 1 Spring Meeting 2012 Presenter - Navigating Your Way to Develop Budgets for NIH Funded and Pharmaceutical Funded Clinical Trials, What s the Difference; NCURA Region 1 Spring Meeting 2013 Presenter -How to be a Successful Research Administrator When Dealing with Clinical 5

6 Trials Budgets and Payment Terms for both NIH and Industry Sponsored Trials ; SoCRA Pediatric Clinical Research Conference - Co-Founder and Presenter February /15 PUBLICATIONS: Benson, L, Ritz, M. A Primer on Clinical Trials For The Research Administrator; Chapters 2 and 4; NCURA 2012 Benson, L Developing Clinical Research Budgets: SoCRA Source. February 2009 Benson, L Centralized Services in Clinical Research: SoCRA Source. November 2007 Benson, L Children s Hospital Saves Time, Money Through Centralized Services: Clinical Trails Administrator. March 2007 Nagle K, Devine S, Krailo M, Benson L, Caso S. Audit Preparation Class: Does It Really Help CRAs? Applied Clinical Trials. June Devine S, Nagel K, Benson L, Krailo M. CRA Discipline Time and Effort Study: Children s Oncology Group. Applied Clinical Trials. April 2005 Zempsky WT, Robbins B, Benson L, Sullivan L, McKay K. Reduction of topical anesthetic onset time using ultrasound: A randomized controlled trial prior to venipuncture in young children. American Academy of Pediatrics National Conference an Exhibition. October 7, 2005 Zempsky WT, Vause E, Sykes D, Robbins B, Benson L, Hoffman M, Richards P, Schechter N. ALGRX 3268 for rapid topical anesthesia in children. Poster Presentation. Pediatric Academic Societies Meeting Washington DC, May 17, 2005 Zempsky WT, Vause E, Sykes D, Robbins B, Benson L, Hoffman M, Richards P, Schechter N. Randomized, double blind, placebo controlled study of ALGRX 3268: A topical lidocaine delivery system for topical anesthesia prior to venipuncture in children. Poster Presentation. American Pain Society, boston, MA Marcy 30- April1, J Pain 2005; 6:S50 ABSTRACTS: 1994 Focal Neurologic Events in Children Following Treatment with Cytarabine and Intrathecal Methotrexate Dr. Michele Kleiman, Dr. Edwin Zalneraitis and Lisa Forte-Benson, CRA 1995 Neuroimaging to Establish Etiology of Seizures in Children with Leukemia Dr. Michele Kleiman, Lisa Forte-Benson, CCRA and Dr. Arnold Altman EDUCATIONAL LECTURES: 2001 GCRC Clinical Research Orientation Course 2003 GCRC Clinical Research Orientation Course 2005 Connecticut Children s Medical Center: Good Clinical Practices 6

7 2007 Connecticut Children s Medical Center: What to Expect from an FDA Audit Connecticut Children s Medical Center: New Clinical Research Associate Training Course Orientation to New Fellows at Connecticut Children s - What the Grants Office can do for You 2014 Connecticut Children s Medical Center: Agreements in Research, Defining the Contract and it s requirements POSTER PRESENTATIONS: 2002 Preparing for an IRB Audit Childrens Oncology Group St. Louis, MI Lisa Benson, CCRP 2005 Time and Effort Study Results - Orlando, FL Susan Devine, CCRP, Kim Nagle, CCRP, Lisa Benson, CCRP and Mark Krailo, PhD CCRP 2006 Good Clinical Practices - Chicago, IL Lisa Benson, CCRP and Bertha Robbins, RNC, CCRP 2007 What to Expect from an FDA Audit - Denver, CO Lisa Benson, CCRP and Bertha Robbins, RNC, CCRP 7