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CRP
Certification, Preparation, and Review Course
Program Information
Registration Fees:
Non-member fee includes membership for one year. Continuing Education Credit Hours: Accreditation Statements: SoCRA Course Series: 500 The CCRP Certification Examination
is offered
throughout the year.
Enrollment in the SoCRA Certification Exam requires a separate application and fee. Please visit HERE for more information. Program DescriptionGoal: The Society of Clinical Research Associates (SoCRA) recognizes Certified Clinical Research Professionals (CCRPs) as clinical researchers who meet an internationally accepted standard of knowledge, education and experience. The purpose of this workshop is to assist the participant in preparing for the SoCRA examination for the Certified Clinical Research Professional examination and to review regulations, policies, and procedures appropriate to the clinical research environment. Please see the Certification page for a separate examination application. Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Learning Objectives: Upon completion of the workshop, the attendee should be able to:
How to RegisterPlease Note: This enrollment registers you in the SoCRA Certification, Preparation and Review Course ONLY. Enrollment in the SoCRA CCRP Certification Exam requires a separate application and fee. Visit HERE for more information. Click HERE to register online!* Click Here to view/print the Course Application in Adobe PDF format.* *SoCRA REGISTRATION POLICIES/INFORMATION:
Click Here to view/print the Course Late Transfer Form (in PDF format). AgendaClick Here to view/print the Course Agenda in Adobe PDF format. Faculty Bios:Course faculty would be one of the following instructors. George D’Addamio is President of PharmConsult, Inc., a consulting company in Atlanta, GA. During 8 years at SmithKline & French Laboratories (now Glaxo SmithKline), Dr. D’Addamio was responsible for preparing protocols, case report forms, integrated study reports, and regulatory submissions in Clinical R&D and Medical Affairs. As Scientific Manager, Clinical R&D, he was responsible for coordinating clinical research programs in Canada, Latin America, and the Pacific conducted under the US IND. In Medical Affairs, he managed operational groups responsible for medical writing, clinical monitoring, and safety reviews and quality control checks of CRFs. After leaving SK&F, Dr. D’Addamio worked for a CRO for 1.5 years before forming PharmConsult in 1987. Previous consulting experience includes project management, data management, statistical services, and medical writing. Currently, PharmConsult specializes in preparation of clinical development documents in various therapeutic areas for domestic and foreign pharmaceutical companies. Susan I. Devine is Senior Manager of the Clinical Trials Support Unit of the Hematology/Oncology/Bone Marrow Transplant Division at the Hospital for Sick Children in Toronto where she also serves as a member of the Advisory Council for the SickKids Cancer Center. She is a past chair of the CRA Discipline Committee of the Children’s Oncology Group and former Board Member and Treasurer of the Society of Clinical Research Associates (SoCRA). With nearly 30 years experience in pediatric cancer clinical trials, she teaches the Certification Prep and Review Course for SoCRA and collaboratively facilitates a Project Management course for the Ontario Institute of Cancer Research (OICR). Ms. Devine is a grant reviewer for NCI’s Committee H, a founding member of the Canadian C17 Research Network in Pediatric Hematology/Oncology, currently co-chairs the C17 Human Resources Committee, and is Principal Investigator of a concordance study testing a workload measurement instrument. Susan is first author of a chapter in Pediatric Clinics of North America entitled Good Clinical Practice and the Conduct of Clinical Studies in Pediatric Oncology and is a contributing author to a series of articles in Journal of Oncology Practice describing attributes of exemplary clinical trial sites. As a member of the American Society of Clinical Oncology (ASCO), she participates on the Exemplary Sites Working Group. Joanne Goldberg, MSc, pht, CCRP, is the Assistant Director of the Canadian Institutes of Health Research’s Institute of Aging in Montreal, Canada. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physical Therapy from the same institution. She has been involved in clinical research for the past 18 years and has held many positions including Associate Director of Scientific Affairs, Director of Training, Director for Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, as well as Investigator. Her expertise is primarily in the development and implementation of international partnerships for health research as well as quality management systems, training in Good Clinical Practices, study methodology, and writing and implementing standard operating procedures. She is responsible for the French language translation and administration of the Society of Clinical Research Associates’ (SoCRA) certification examination and Preparatory Course. Joanne is a member of the SoCRA Certification Committee and is a Past President of the Society. Carolyn E. Rugloski, MSc, CCRP, FCI Director Project Management, provides consulting services and customized training solutions through Fairplay Consultants, Inc (FCI). Ms. Rugloski was Associate Director, Clinical Operations at the University of California at San Francisco ITN (Immune Tolerance Network) where she managed the Transplantation Portfolio; before working at ITN she was Director, Training and Standards, MedImmune Medical Organization, where she led a two-year launch of the combined training and compliance initiative. Ms. Rugloski has over twenty-five years of clinical trial experience managing, leading, and directing clinical operations teams, including: data management, monitoring, training, project management, quality assurance, and business development. Through SoCRA and other educational organizations, Ms. Rugloski continues to advocate and implement forward-thinking, blended learning solutions in the training of clinical trial professionals. Recognized internationally as a Good Clinical Practice (GCP) subject matter expert, Ms. Rugloski has lectured in North America, Europe, and the Pacific Rim on various clinical research topics. Ms. Rugloski is a past member of the SoCRA Board of Directors and continues to assist in the development and delivery of SoCRA events. Kathi Durdon, MA, CCRP, is a Clinical Operations Associate with device manufacturer, Welch Allyn, Inc., based in Skaneateles Falls, NY. Previously, Ms. Durdon directed the Clinical Trials Office at State University of New York (SUNY) Upstate Medical University in Syracuse, NY. Kathi has been responsible for development of medical conferences and comprehensive education programs as well as resource development and budget negotiation throughout her 15-year tenure at Upstate. As CRA at Welch Allyn, she provides GCP and GMP training, SOP development and all aspects of project management for device clinical trials. Kathi is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional, speaks frequently at SoCRA courses, is a member of SoCRA’s Board of Directors and is the New York State Chapter Chair. Ms. Durdon holds Bachelor of Arts degrees in both English and Anthropology from the State University of New York (SUNY) Potsdam College as well as a Master of Arts degree in Business Policy from the State University of New York (SUNY) Empire State College. How to Host This CourseThe CRP Certification, Preparation, and Review Course Host Application is available in Microsoft Word format.
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