Leadership within the CRCU
The leadership of the CRCU consists of two faculty co-directors and a team of six staff directors. In 2004 the staff leadership model was expanded from the original two senior directors to include four managing directors, each leading a discipline-specific subunit within the CRCU. The original co-directors now focus their leadership efforts on technology infrastructure, new methodologies, special projects and proposal development.
Faculty Co-Directors:J. Richard Landis, Ph.D., Professor of Biostatistics, was recruited to the University of Pennsylvania in 1997 to provide overall leadership for academic and collaborative research programs in Biostatistics. In order to facilitate the conduct of Data Coordinating Centers (DCCs) for multi-center clinical trials and clinical research networks (CRNs), he founded the CRCU in 1997, and successfully obtained funding for two large-scale DCCs in 1997-98. Currently, he serves as PI or Co-PI of the DCC for six multicenter clinical research networks, all coordinated within the CRCU. He is also PI of a recently awarded NIH Roadmap Program for "Harmonizing NIH- and Industry-Sponsored Clinical Research Networks." Dr. Landis is Director of the Biostatistics Unit within the CCEB and, together with Dr. Feldman, serves as Vice-Chair of the Department of Biostatistics and Epidemiology. He also holds a secondary appointment as Professor of Statistics in the Wharton School. Previously, Dr. Landis was Professor of Biostatistics and Statistics at The Pennsylvania State University for nine years, where he founded and directed the Center for Biostatistics and Epidemiology (CBE) within the M.S. Hershey Medical Center. Prior to that, he served on the Biostatistics faculty at the University of Michigan for 13 years.
Harold I. Feldman, M.D., M.S.C.E., Professor of Medicine and Epidemiology, arrived at Penn in 1985 after earning his M.D. degree at Boston University and completing his internship and residency in internal medicine at UCLA. As an Andrew W. Mellow Fellow in Clinical Epidemiology, Dr. Feldman earned his M.S.C.E. degree from the Penn School of Medicine. He also completed a nephrology fellowship in the Renal-Electrolyte and Hypertension Division at Penn. Dr. Feldman joined the faculty as Assistant Professor of Medicine in 1988 with an additional appointment as Senior Scholar of the CCEB, and Assistant Professor of Epidemiology in 1995 in the newly chartered Department of Biostatistics and Epidemiology. Dr. Feldman has also been a long-standing Senior Fellow of the Leonard Davis Institute for Health Economics. When Dr. Feldman was promoted to the rank of Associate Professor of Medicine and Epidemiology in 1999, he also took over the leadership of the Clinical Epidemiology Unit of the CCEB and the Division of Epidemiology the following year. Along with Dr. Landis, Dr. Feldman serves as Vice-Chair of the Department of Biostatistics and Epidemiology. He has been the PI of numerous federal and foundation grants totaling more than $25 million, principally focusing on various aspects of chronic kidney disease. Among these, Dr. Feldman leads the Chronic Renal Insufficiency Cohort Study's Scientific and Data Coordinating Center at Penn, one of the CRCU's largest coordinating center projects. Dr. Feldman also maintains a small ambulatory in-patient consultative practice in nephrology.
Senior Directors:Robert M. Curley, M.S., Senior Director for Methodologies and Special Projects, is responsible for (i) leadership of scientific and resource aspects of Proposal Development; (ii) project implementation for special programs such as the Penn Roadmap Program for "Re-engineering the Clinical Research Enterprise" and the Penn Clinical Research Informatics initiative with Oracle Clinical; and (iii) strategic leadership for development of scientific and organizational methodologies. For the past 20 years, Mr. Curley has provided leadership in establishing and managing scientific and computing facilities dedicated to basic and clinical research. He has extensive experience with project management, clinical data management, clinical research informatics, quality assurance and regulatory compliance, and application of computing technology to basic and clinical research. He has also led the primary development efforts for the CRCU in supporting multiple Data Coordinating Centers (DCCs).
James L. Kaylor, M.S.E., C.I.S.M., Senior Director for Biomedical research Computing (BRC), is responsible for investigating, designing, and implementing new information technology infrastructures, systems, and compliance/business processes in support of the CCEB and the clinical research mission of the University. For the past 21 years, Mr. Kaylor has been responsible for the development and management of various computing facilities, within both government and medical research institutions. In addition to clinical data management experience, he has specialized experience in the development of computing hardware, system software and application development, database development and administration, network infrastructures, and IT security practices. He is a Certified Information Security Manager (CISM), as qualified through the Information Systems Audit and Control Association (ISACA).
Managing Directors:Denise Cifelli, M.S., Director for Project Operations and Compliance (POCO), is responsible for the overall leadership of POCO within the CRCU. In this role, she provides senior leadership for the Project Management staff in their management of more than 40 funded projects within the CRCU. Ms. Cifelli has more than 12 years of project management experience, including several large multi-center clinical research networks, and most recently Penn's coordinating role for the NIH BAA Roadmap Programs. Ms. Cifelli is a certified teacher, licensed in Pennsylvania, and a Certified Clinical Research Associate.
Stephen B. Durborow, B.S., Director for Research Technologies (RT), is responsible for the overall leadership for the Software Systems Division (SSD) and the Database Services Division (DSD). He provides direct leadership for two divisional technical directors, who lead the software and database design and development activities across all CRCU projects. Mr. Durborow has over 20 years of experience performing and managing software development, database design, and database administration, focusing the last 10 on clinical research. He is responsible for the implementation of technologies new to the CRCU, like Oracle Clinical, in support of the NIH BAA Roadmap and other CRCU projects. Mr. Durborow is also certified in Oracle Database Administration.
Rikki R. Godshall, B.A., IT Director for Biomedical Research Computing (BRC), is responsible for the ongoing operations of the data center-based computing resources of the CCEB. In this role, he provides direct leadership to a staff of senior technical professionals involving the various critical computing infrastructures of storage, servers (*nix, windows, etc.), grid computing, network security and management. Mr. Godshall has over 21 years in developing IT business solutions, with 15 years directly developing computing solutions within the healthcare arena. He has worked the past 10 years within the existing CRCU unit in increasing areas of responsibilities, with concentrated specialty areas of network security and firewalls, and is a certified Solaris Systems Administrator.
Christopher P. Helker, M.S.P.H., Director for Clinical Data Management (CDM), is responsible for the overall leadership of Clinical Data Management within the CRCU. In this role, he provides senior leadership for the CDM staff in their conduct of data management and quality assurance procedures across the broad array of funded projects within the CRCU. Prior to joining the CRCU in 2000, he served as Coordinator for Penn's AIDS Clinical Trials Unit. Mr. Helker is a Certified Clinical Data Manager (CCDM) and a registered nurse, licensed within Pennsylvania.
Financial Management of the CRCU
Janet Conway, Director of Financial and Administrative Operations for the CCEB, provides oversight for the business operations of the CRCU. Denise Tremblay, CCEB Financial Manager, provides financial reporting and detailed analyses. All business transactions for the CRCU flow through the CCEB's business office.
CRCU Personnel Organization, Roles, and ActivitiesThe CRCU provides a comprehensive array of technical and non-technical services in Project Operations and Compliance (POCO), Clinical Data Management (CDM), Research Technologies (RT), and Biomedical Research Computing (BRC) A technical implementation team supports each clinical research project. CRCU personnel totals 44, of which 38 are distributed as follows: POCO (11), CDM (12), RT (9), BRC (4), RDQA (2).
CRCU teams have the following responsibilities:
- Project Operations and Compliance (POCO) personnel plan, develop and coordinate all quality assurance and regulatory compliance activities of the CRCU technical implementation team, the scientific team, and other organizational bodies associated with the project. Additionally, they provide technical document and advanced office document preparation and handling support to the various CRCU operational units.
- Clinical Data Management (CDM) personnel develop and implement data management processes, including data collection, processing, and quality assurance activities, consistent with the scientific protocol.
- Research Technologies (RT) personnel design and develop the underlying database and administrate the use and security of the database as well as utilize specialized methodologies to develop electronic Data Management Systems (DMS), which allows Clinical Center and Data Management personnel to accomplish data management and quality assurance tasks.
- Biomedical Research Computing (BRC) personnel design and develop physical networking schemes and systems to support the computing equipment associated with the Data Management System, and support services for the research computing needs of the CCEB.
- Research Development and Internal Operations QA (RDQA) personnel provide the risk management, project tracking, and proposal development activities across all the projects within the CRCU. Time accounting and project metrics are also the responsibility of this unit.